U.S. Secretary of Defense Austin Issues Guidance for Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members | site |
(Information contained in U.S. Department of Defense [DOD] press release dated: August 25, 2021)
Today, Secretary of Defense Lloyd J. Austin III issued a memorandum for Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members.
The memo directs the Secretaries of the Military Departments to immediately begin full vaccination of all members of the Armed Forces under DoD authority on active duty or in the Ready Reserve, including the National Guard, who are not fully vaccinated against COVID-19.
Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance. Service members voluntarily immunized with a COVID-19 vaccine u...
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U.S. Secretary of Defense Austin Issues Guidance for Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members
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U.S. Department of Labor sues New York Health Center and its CEO for Firing Employee who Reported Coronavirus Safety Concerns
U.S. Department of Labor sues New York Health Center and its CEO for Firing Employee who Reported Coronavirus Safety Concerns | site |
Alleges defendants violated Occupational Safety and Health Act anti-retaliation provisions
(Information contained in U.S. Department of Labor press release dated: June 1, 2021) New York - - The U.S. Department of Labor is suing a Staten Island community health center and its CEO after they suspended and later fired an employee who reported coronavirus-related health and safety hazards, including possibly exposing staff to the virus and lack of proper social distancing protocols. The employee raised concern to company management that in-person attendance at a March 2020 staff meeting could lead to transmission and contraction of the virus. The worker attempted to reschedule the meeting by telephone, but ultimately refused to attend the meeting in-person after management refused the scheduling ... -
Treasury Launches Coronavirus State and Local Fiscal Recovery Funds to Deliver 350 Billion Dollars
U.S. Department of the Treasury Launches Coronavirus State and Local Fiscal Recovery Funds to Deliver $350 Billion | site |
Aid to state, local, territorial, and Tribal governments will help bring back jobs, address pandemic’s economic fallout, and lay the foundation for a strong, equitable recovery
(Information contained in U.S. Department of the Treasury press release dated: May 10, 2021)
Washington - - Today, the U.S. Department of the Treasury announced the launch of the Coronavirus State and Local Fiscal Recovery Funds, established by the American Rescue Plan Act of 2021, to provide $350 billion in emergency funding for state, local, territorial, and Tribal governments. Treasury also released details on the ways funds can be used to respond to acute pandemic-response needs, fill revenue shortfalls among state and local governments, and support the communities and populations hardest-hit by the COVID-19 crisis. Eligible state,... -
Coronavirus COVID-19 Update - - FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs
Coronavirus (COVID-19) Update: FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 16, 2021)
The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health
March 16, 2021
Statement From:
Director - CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomati... -
Excerpt of FDA Coronavirus COVID-19 Update - - - March 12, 2021
Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update: March 12, 2021 | site |
(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: March 12, 2021)- Today, the FDA issued a Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff and Health Care Providers to alert them that false positive results can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System.
- Today, the FDA issued an Emergency Use Authorization (EUA) for Propofol-Lipuro 1% injectable emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved
-
U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021
U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
- On Friday the FDA issued
-
Coronavirus COVID-19 Update - - - FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test
Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. “Today’s authorization further underscores the FDA’s commitment to innovation in test development,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understandi... -
FDA Coronavirus COVID-19 Update - - - March 5, 2021
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors
-
Coronavirus COVID-19 Update - - - FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test
Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Issues Authorization for First Molecular Non-Prescription, At-Home Test | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. “The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. ... -
Coronavirus COVID-19 Update - - - March 2, 2021
Coronavirus (COVID-19) Update: March 2, 2021 | site |
(Information contained in U.S. Food and Drug Administration press release dated: March 2, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
- The agency issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription at-home use with a self-collected nasal swab sample
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Coronavirus COVID-19 Update - - - FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 1, 2021)
Statement From:
Director - CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis. The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healt... -
Coronavirus COVID-19 Update - - - FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine | site |
Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 25, 2021) Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).... -
Coronavirus (COVID-19) Update: February 23, 2021
Coronavirus (COVID-19) Update: February 23, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 23, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Yesterday, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19
- The FDA issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. The Pulse Oximeter Accuracy and Limitations: FDA Safety Communication provides:
- Important recommendations for patients and their caregivers on how to use pulse oximeters at home.
- Recommendations for health
-
Coronavirus COVID-19 Update - - - February 12, 2021
Coronavirus COVID-19 Update - - - February 12, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 12, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- This week, the FDA posted the webpage, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA’s Center for Biologics Evaluation and Research is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention, the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, and other academic and large non-government healthcare data systems.
- This week, the FDA issued an emergency use authorization (EUA) for a a monoclonal antibody combination for the treatment of mild
-
Coronavirus COVID-19 - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 9, 2021)
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death d...
-
U.S. Secretary of Defense Austin Issues Guidance for Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members | site |
(Information contained in U.S. Department of Defense [DOD] press release dated: August 25, 2021) Today, Secretary of Defense Lloyd J. Austin III issued a memorandum for Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members. The memo directs the Secretaries of the Military Departments to immediately begin full vaccination of all members of the Armed Forces under DoD authority on active duty or in the Ready Reserve, including the National Guard, who are not fully vaccinated against COVID-19. Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance. Service members voluntarily immunized with a COVID-19 vaccine u...08-25-2021, 02:06 PM -
U.S. Department of Labor sues New York Health Center and its CEO for Firing Employee who Reported Coronavirus Safety Concerns | site |
Alleges defendants violated Occupational Safety and Health Act anti-retaliation provisions
(Information contained in U.S. Department of Labor press release dated: June 1, 2021) New York - - The U.S. Department of Labor is suing a Staten Island community health center and its CEO after they suspended and later fired an employee who reported coronavirus-related health and safety hazards, including possibly exposing staff to the virus and lack of proper social distancing protocols. The employee raised concern to company management that in-person attendance at a March 2020 staff meeting could lead to transmission and contraction of the virus. The worker attempted to reschedule the meeting by telephone, but ultimately refused to attend the meeting in-person after management refused the scheduling ...06-08-2021, 06:54 PM -
U.S. Department of the Treasury Launches Coronavirus State and Local Fiscal Recovery Funds to Deliver $350 Billion | site |
Aid to state, local, territorial, and Tribal governments will help bring back jobs, address pandemic’s economic fallout, and lay the foundation for a strong, equitable recovery
(Information contained in U.S. Department of the Treasury press release dated: May 10, 2021)
Washington - - Today, the U.S. Department of the Treasury announced the launch of the Coronavirus State and Local Fiscal Recovery Funds, established by the American Rescue Plan Act of 2021, to provide $350 billion in emergency funding for state, local, territorial, and Tribal governments. Treasury also released details on the ways funds can be used to respond to acute pandemic-response needs, fill revenue shortfalls among state and local governments, and support the communities and populations hardest-hit by the COVID-19 crisis. Eligible state,...05-10-2021, 08:10 PM -
Coronavirus (COVID-19) Update: FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 16, 2021)
The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health
March 16, 2021
Statement From:
Director - CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomati...03-22-2021, 07:14 PM -
Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update: March 12, 2021 | site |
(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: March 12, 2021)- Today, the FDA issued a Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff and Health Care Providers to alert them that false positive results can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System.
- Today, the FDA issued an Emergency Use Authorization (EUA) for Propofol-Lipuro 1% injectable emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved
03-15-2021, 05:40 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
- On Friday the FDA issued
03-10-2021, 09:14 AM -
Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. “Today’s authorization further underscores the FDA’s commitment to innovation in test development,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understandi...03-08-2021, 08:12 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors
03-08-2021, 05:10 AM -
Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Issues Authorization for First Molecular Non-Prescription, At-Home Test | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. “The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. ...03-08-2021, 01:06 AM -
Coronavirus (COVID-19) Update: March 2, 2021 | site |
(Information contained in U.S. Food and Drug Administration press release dated: March 2, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
- The agency issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription at-home use with a self-collected nasal swab sample
03-05-2021, 07:26 PM -
Coronavirus COVID-19 Update - - - FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 TestCoronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 1, 2021)
Statement From:
Director - CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis. The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healt...03-05-2021, 03:37 PM -
Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine | site |
Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 25, 2021) Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)....02-26-2021, 01:08 AM -
Coronavirus (COVID-19) Update: February 23, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 23, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Yesterday, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19
- The FDA issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. The Pulse Oximeter Accuracy and Limitations: FDA Safety Communication provides:
- Important recommendations for patients and their caregivers on how to use pulse oximeters at home.
- Recommendations for health
02-25-2021, 10:24 PM -
Coronavirus COVID-19 Update - - - February 12, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 12, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- This week, the FDA posted the webpage, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA’s Center for Biologics Evaluation and Research is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention, the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, and other academic and large non-government healthcare data systems.
- This week, the FDA issued an emergency use authorization (EUA) for a a monoclonal antibody combination for the treatment of mild
02-13-2021, 02:22 AM -
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 9, 2021)
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death d...02-10-2021, 01:46 AM -
Coronavirus (COVID-19) Update: February 9, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 9, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA issued a Letter to Health Care Providers on Using Ventilator Splitters During the COVID-19 Pandemic to provide up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. The Letter to Health Care Providers also includes important information about ventilator splitters, including descriptions of features that may reduce certain risks associated with the use of ventilator splitters, considerations for health care providers and facilities when using ventilator splitters, and instructions for
02-09-2021, 06:17 PM -
Coronavirus (COVID-19) Update: February 5, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 5, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be added for individual meetings as needed. The
02-08-2021, 07:47 AM -
Coronavirus (COVID-19) Update: January 29, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 29, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- This week, the FDA added a new frequently asked question (FAQ), “Can the FDA help me get a COVID-19 vaccine,” to our COVID-19 FAQs, under the vaccine section. The answer is no. The FDA’s authority includes authorizing or approving COVID-19 vaccines for use in the United States. The FDA is not responsible for vaccine distribution. Go to the CDC website to find your state and local health departments who are responsible for COVID-19 vaccine distribution. If you are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam.
- The FDA has added content to the question-and-answer appendix in its
01-29-2021, 09:32 PM -
Interior Department Welcomes Day One Executive Orders to Restore Public Lands and Waters, Combat Coronavirus | site |
(Information contained in U.S. Department of the Interior press release FACT SHEET dated: January 21, 2021)
Washington, D.C. — Immediately following his inauguration, President Joe Biden signed Executive Orders that take critical first steps to address the climate crisis, create good union jobs, and advance environmental justice, while reversing the previous administration’s harmful policies.
One of President Biden’s Executive Orders requires the Interior Department to conduct a review of the monument boundaries and conditions of the Grand Staircase-Escalante, Bears Ears, Northeast Canyons, and Seamounts Marine National Monuments. The order directs Interior, in consultation with other agencies and Tribal governments, to determine whether restoration of the monument boundaries and conditions would be...01-28-2021, 12:03 AM -
USDA Temporarily Suspends Debt Collections, Foreclosures and Other Activities on Farm Loans for Several Thousand Distressed Borrowers Due to Coronavirus | site |
(Information contained in U.S. Department of Agriculture [USDA] press release dated: January 27, 2021)
Washington, Jan. 27, 2021 - - Due to the national public health emergency caused by coronavirus disease 2019 (COVID-19), the U.S. Department of Agriculture today announced the temporary suspension of past-due debt collections and foreclosures for distressed borrowers under the Farm Storage Facility Loan and the Direct Farm Loan programs administered by the Farm Service Agency (FSA). USDA will temporarily suspend non-judicial foreclosures, debt offsets or wage garnishments, and referring foreclosures to the Department of Justice; and USDA will work with the U.S. Attorney’s Office to stop judicial foreclosures and evictions on accounts that were previously referred...01-27-2021, 07:54 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 26, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 26, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on the FDA's response efforts.
- FDA has posted a CDER Conversation with Katie Gray, Pharm.D., acting director of CDER’s Office of Prescription Drug Promotion (OPDP). This Conversation describes OPDP’s COVID-19 response, which has focused on compliance actions regarding prescription drug promotional materials making false or misleading claims about COVID-19 prevention or treatment. The Conversation also discusses OPDP’s 2020 achievements and 2021 goals, and the way
01-27-2021, 01:20 AM -
Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers | site |
(Information contained in U.S. Food and Drug Administration [FDA] news release dated: January 26, 2021)
As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination....01-27-2021, 12:29 AM -
Excerpt of U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 22, 2021 | site |
(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: January 22, 2021)- The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simula
01-22-2021, 07:41 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 19, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: January 19, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, to help protect consumers from methanol poisoning, the FDA issued a new guidance, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs. Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects.
- To accelerate the adoption of advanced and smart manufacturing
01-19-2021, 06:14 PM -
USDA Offers Additional Assistance for Certain Producers Through Coronavirus Food Assistance Program | site |
(Information contained in U.S. Department of Agriculture press release dated: January 15, 2021) (Washington, D.C., January 15, 2021) – U.S. Secretary of Agriculture Sonny Perdue announced the U.S. Department of Agriculture (USDA) will provide additional assistance through the Coronavirus Food Assistance Program (CFAP), expanding eligibility for some agricultural producers and commodities as well as updating payments to accurately compensate some producers who already applied for the program. Producers who are now eligible and those who need to modify existing applications due to these updates can contact USDA’s Farm Service Agency (FSA) between Jan. 19 and Feb. 26. Some of these changes are being made to align with the recently enacted Consolidated Appropriations Act of 2021 while others are discretionary changes being made in response...01-19-2021, 06:27 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.” This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency.
- On January 14, the FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement
01-16-2021, 11:15 PM -
Coronavirus (COVID-19) Update: January 8, 2021 | site |
(The following is part of the information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021)
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:- The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
- Details on the effect of genetic variants on test performance.
- Recommendations for clinical laboratory staff and health care providers.
- Actions the FDA has taken.
- Instructions for reporting problems with a test.
- This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently
01-08-2021, 11:39 PM - The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
-
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 5, 2021 | site |
(Information included in U.S. Food and Drug Administration [FDA] press release dated: January 5, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.
The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA. Include...01-05-2021, 08:05 PM -
U.S. Department of Labor publishes Guidance on Expiration of Paid Sick Leave and Expanded Family and Medical Leave for Coronavirus | site |
(Information contained in U.S. Department of Labor press release dated: December 31, 2020)
Washington, DC - - The U.S. Department of Labor’s Wage and Hour Division (WHD) today announced additional guidance to provide information to workers and employers about protections and relief offered by the Families First Coronavirus Response Act (FFCRA). The FFCRA’s paid sick leave and expanded family and medical leave requirements will expire on Dec. 31, 2020.
The new guidance, in the form of Frequently Asked Questions on the WHD website, addresses whether workers who did not use their leave entitlement under the FFCRA in 2020 may use such leave after Dec. 31, 2020. It also explains how WHD will maintain its enforcement authority over employers’ leave responsibilities while the FFCRA’s paid leave...01-02-2021, 01:50 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 30, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 30, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.
- In a new FDA Voices entitled, 2020 at FDA: A Year of Unparalleled Contributions to Public Health, FDA Commissioner
12-31-2020, 12:26 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 28, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, the FDA added the following device types in the testing supplies and equipment category: pipette tips (product codes LXG and PPM) and micro pipettes (product code JRC). The FDA also added clarifying notes and links to more resources in the “Additional Information” column, as well as adding clarity to the categories, such as grouping gloves under “Personal Protective Equipment – Gloves.” The device shortage list reflects the categories of
12-29-2020, 05:17 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 22, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 22, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA has posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers, and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
- The FDA recently approved three abbreviated new drug applications (ANDAs):
On Dec. 18, one ANDA for etomidate injection, indicated for the induction of general anesthesia. The most common side effects of etomidate injection are venous pain on injection and...12-24-2020, 01:30 AM -
Statement by U.S. Treasury Secretary Steven T. Mnuchin on Passage of the Coronavirus Response and Relief Supplemental Appropriations Act | site |
(Information contained in U.S. Department of the Treasury press release statement: December 22, 2020)
Statement by Secretary Steven T. Mnuchin on Passage of the Coronavirus Response and Relief Supplemental Appropriations Act
Washington - - Secretary Steven T. Mnuchin issued the following statement on passage of the Coronavirus Response and Relief Supplemental Appropriations Act as part of the Consolidated Appropriations Act of 2021: “I am pleased that the United States Senate and House of Representatives have passed on an overwhelmingly bipartisan basis the Coronavirus Response and Relief Supplemental Appropriations Act, as part of the Consolidated Appropriations Act of 2021. I want to thank President Trump for his leadership and Leader McConnell, Leader Schumer, Speaker Pel...12-22-2020, 12:46 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 21, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 21, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
- Today, the agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on
12-22-2020, 02:03 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 17, 2020| site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 17, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met to discuss a request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by ModernaTX, Inc. This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.
- Also
12-18-2020, 07:24 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 16, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 16, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who
12-17-2020, 07:14 PM -
National Institutes of Health Observational Study of Coronavirus Infection and Multisystem Inflammatory Syndrome in Children Begins | site |
(Information contained in National Institutes of Health [NIH] press release: December 16, 2020) An observational study has launched to evaluate the short- and long-term health outcomes of SARS-CoV-2 infection in children, including multisystem inflammatory syndrome in children (MIS-C), and to characterize the immunologic pathways associated with different disease presentations and outcomes. SARS-CoV-2 is the virus that causes COVID-19. The study, called the Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM), will enroll at least 250 children and young adults ages 20 years or younger from diverse racial and ethnic backgrounds at approximately 20 sites nationwide. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the study. ...12-16-2020, 08:06 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The test will b...12-16-2020, 04:47 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | site |
Test is authorized for individuals two years of age or older, including those not showing symptoms
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 15, 2020)
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-c...12-16-2020, 12:34 AM -
Excerpts from U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 14, 2020 | site |
(The following are EXCERPTS from information contained in a U.S. Food and Drug Administration [FDA] press release: December 14, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine. To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible.
- On Dec. 11, the agency approved an abbreviated new drug application for midazolam injection, indicated for preoperative sedation/anxiolysis (anxiety)/amnesia; as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic
12-15-2020, 04:57 AM -
Coronavirus (COVID-19) Update: December 10, 2020 | site |
(Information contained in U.S. Food and Drug Administration press release: December 10, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met to discuss the first request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.
This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.- [
12-11-2020, 12:46 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System | site |
Test system is authorized for at-home sample collection with laboratory test processing
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 9, 2020) Today, the U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal. This home sample collection kit can be purchased online or in ...12-10-2020, 01:25 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 8, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 8, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA posted online background material for this week’s upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) public meeting. The VRBPAC will meet in open session on Thursday, Dec. 10, to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
- On Dec. 7, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care
12-08-2020, 11:04 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020) Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collec...12-05-2020, 02:02 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 4, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA issued a guidance, “Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency.” This guidance provides the FDA’s enforcement policy regarding certain requirements for mammography facilities and general considerations in response to common scenarios faced by mammography facilities as a result of the COVID-19 public health emergency.
- On Dec. 3, the agency issued an Emergency Use Authorization (EUA) for the Lumin LM3000 Bioburden Reduction UV System, the first ultraviolet-C (UV-C) light based bioburden reduction system for emergency use
12-05-2020, 12:02 AM -
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: November 30, 2020) The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. “In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts from around the country, will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA understands there is tremendous public interest regarding vaccines for COVID-19. ...12-01-2020, 06:23 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 24, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: November 24, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA today published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators. The topics covered in this new page include:
- The basics on face masks, surgical masks, and respirators
- Using face masks, surgical masks, and respirators
- Shortages of face masks, surgical masks, and respirators during COVID-19
- The Emergency Use Authorizations for face masks, surgical masks, and respirators
- Manufacturing and importing face masks, surgical masks, and respirators during
11-24-2020, 11:42 PM - The FDA today published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators. The topics covered in this new page include:
-
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 23, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020)
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:- On Nov. 20, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American
11-24-2020, 05:23 AM -
U.S. Department of Housing and Urban Development announces over $80 Million in Targeted Funding for Coronavirus Relief | site |
Mainstream Vouchers aid non-elderly populations with disabilities in response to, and recovery from, COVID-19
(Information contained in U.S. Department of Housing and Urban Development press release: November 17, 2020)
Washington - - The U.S. Department of Housing and Urban Development (HUD) today made $86.85 million available to public housing agencies (PHAs) in the form of Mainstream funding vouchers to assist non-elderly populations impacted by Coronavirus. Mainstream Vouchers are administered using the same rules as other housing choice vouchers but targeted to serve a special population to ensure residents of low income housing, including those with unique circumstances, receive necessary funding to protect their health and safety against COVID-19. “Recently, we have learned a great deal about Coron...11-21-2020, 08:38 PM -
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: November 20, 2020)
The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.
“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and...11-21-2020, 05:04 AM -
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |
(Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)
November 19, 2020
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...11-20-2020, 03:08 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home | site |
(November 17, 2020) - - On November 17, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic ...11-18-2020, 04:39 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 17, 2020 | site |
(November 17, 2020) - - On November 17, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA reaffirmed its commitment to transparency around the EUA process and shared updates on its plan to provide more information about the agency’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines, as part of our COVID-19 response. FDA is taking additional steps to promote transparency and public confidence in the agency’s scientific review process and the appropriate use of these products authorized for emergency use by posting, to the extent appropriate and permitted by law, the scientific reviews for EUAs issued, revised, or revoked
11-18-2020, 03:40 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 16, 2020 | site |
(November 16, 2020) - - The U.S. Food and Drug Administration (FDA) published (today) the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA. The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine.
- The agency
11-17-2020, 01:24 PM -
U.S. Department of Labor's OSHA announces $2,856,533 in Coronavirus Violations | site |
(November 13, 2020) - - On November 13, 2020 the U.S. Department of Labor published information that included the following:
WASHINGTON, DC – Since the start of the coronavirus pandemic through Nov. 5, 2020, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has issued 204 citations arising from inspections for violations relating to coronavirus, resulting in proposed penalties totaling $2,856,533.
OSHA inspections have resulted in the agency citing employers for violations, including failures to:- Implement a written respiratory protection program;
- Provide a medical evaluation, respirator fit test, training on the proper use of a respirator and personal protective equipment;
- Report an injury, illness or fatality;
- Record an injury or illness on OSHA recordkeeping forms; and
- Comply with the General Duty Clause of
11-16-2020, 02:20 AM -
Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Authorizes Monoclonal Antibody for Treatment of COVID-19 | site |
(November 9, 2020) - - On November 9, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima...11-10-2020, 07:37 AM -
U.S. Department of Labor says it acts to help American Workers and Employers during the Coronavirus Pandemic | site |
(November 9, 2020) - - Today the U.S. Department of Labor published the following information:
WASHINGTON, DC – Last week, the U.S. Department of Labor took a range of actions to aid American workers and employers as our nation combats the coronavirus pandemic.
Reopening America’s Economy:- Statement by U.S. Secretary of Labor Scalia on the October Jobs Report – U.S. Secretary of Labor Eugene Scalia issued the following statement on the October 2020 Employment Situation Report: “The strong economic rebound continues, with approximately 900,000 private sector jobs gained back in September and again in October, and the October unemployment rate dropping a full point, to 6.9 percent.”
11-09-2020, 07:23 PM -
Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection| site |
(November 6, 2020) - - On November 6, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody. Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but ...11-07-2020, 02:33 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: October 28, 2020 | site |
(October 28, 2020) - - Today, October 28, 2020, the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA updated an immediately in effect guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This update expands the scope of the guidance to include an additional device type: Gaseous-Phase Carbon-Dioxide Gas Analyzer (product code CCK), which includes capnographs and devices with a capnography feature.
- Yesterday, the FDA approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical
10-31-2020, 12:14 AM -
U.S. Department of Agriculture says More than $7 Billion Paid in Second Round of USDA Coronavirus Food Assistance Program | site |
(October 26, 2020) - - Today, October 26, 2020, the U.S. Department of Agriculture (USDA) published the following information: (Washington, D.C., Oct. 26, 2020) – U.S. Secretary of Agriculture Sonny Perdue today announced that in the first month of the application period, the USDA Farm Service Agency (FSA) approved more than $7 billion in payments to producers in the second round of the Coronavirus Food Assistance Program. CFAP 2 provides agricultural producers with financial assistance to help absorb some of the increased marketing costs associated with the COVID-19 pandemic. “America’s agriculture communities are resilient, but still face many challenges due to the COVID-19 pandemic. These payments directed by President Trump will continue to help this critical industry recoup some of their losses from ongoing market disrupti...10-27-2020, 02:37 PM -
U.S. Small Business Administration Offers Disaster Assistance to Maryland Small Businesses Economically Impacted by the Coronavirus (COVID-19) | site |
(October 20, 2020) - - Today, October 20, 2020, the U.S. Small Business Administration (SBA) published the following information:
ATLANTA – The U.S. Small Business Administration is offering low-interest federal disaster loans for working capital to Maryland small businesses suffering substantial economic injury as a result of the Coronavirus (COVID-19), SBA Administrator Jovita Carranza announced today. SBA acted under its own authority, as provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act that was recently signed by the President, to declare a disaster following a request received from Gov. Larry Hogan on March 18, 2020.
The disaster declaration makes SBA assistance available in the entire state of Maryland; District of Columbia and the...10-23-2020, 06:35 AM -
Johns Hopkins Covid-19 Story Tip: Lessons From A Disease Of Aging May Block Coronavirus Infection | site |
(October 20, 2020) - - Today, October 20, 2020, Johns Hopkins Medicine published the following information:
"Our researchers are studying a potential connection between #COVID-19 and a premature aging disease called progeria. An enzyme linked to progeria may be able to defend against the virus that causes COVID-19." (Quote from Johns Hopkins Medicine)
An enzyme linked to a premature aging disease called progeria may also defend against viruses, including SARS-CoV-2, which causes COVID-19.
The enzyme, called membrane-associated zinc metalloprotease ZMPSTE24, was discovered by the laboratory of Susan Michaelis, Ph.D. She has spent the last several decades studying the enzyme and its effect on a protein called lamin A, which is critical to maintaining the structure of the nucleus, a cell’s control center. M...10-23-2020, 04:50 AM -
U.S. Food and Drug Administration Coronavirus - - - COVID-19 - - - Update: Daily Roundup October 13, 2020 | site |
(October 13, 2020) - - Today, October 13, 2020, the U.S. Food and Drug Administration published the following information:
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:- Today, the FDA issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Many molecular influenza (flu) viruses and respiratory syncytial viruses (RSV) tests require the same critical components as many SARS-CoV-2 molecular assays. The policy outlined in this guidance aims to help expand access to certain FDA-cleared molecular tests intended for detection and identification of flu viruses, including molecular influenza tests that also detect and identify
10-14-2020, 11:27 PM -
U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup September 18, 2020 | site |
(September 18, 2020) - - Today, September 18, 2020, the U.S. Food and Drug Administration published the following information:
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:- The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to:
- Indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.”
- Clarify that testing is authorized for laboratories certified under CLIA and meet the requirements to perform high, moderate, or waived complexity tests.
- Clarify that testing facilities within the United States and its territories
09-21-2020, 05:14 PM - The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to:
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U.S. Department of Housing and Urban Development provides $100 Million in CARES ACT Funding to Native American Tribes to support Coronavirus Recovery Efforts | site |
(August 31, 2020) - - The U.S. Department of Housing and Urban Development published (today) the following information:
WASHINGTON - Today, the U.S. Department of Housing and Urban Development (HUD) Secretary Ben Carson announced that HUD has awarded a total of $100 million to Tribes across the Nation as part of HUD’s Indian Community Development Block Grant Imminent Threat program (ICDBG-CARES). This funding helps address problems that pose an imminent threat to public health or safety of Tribal residents and will be used to help Tribes prevent, prepare for, and respond to COVID-19. See list of funding here.
“The Trump Administration is committed to helping families throughout Indian Country to access essential resources during the coronavirus outbreak,” said Secretary...08-31-2020, 01:29 PM -
Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020| site |
(May 28, 2020) - - Today (May 28, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials
05-29-2020, 02:26 AM -
Centers for Disease Control and Prevention says United States Coronavirus (COVID-19) Death Toll Surpasses 100,000 | site |
May 28, 2020) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information: Today the number of people in the United States who have died from COVID-19 surpassed 100,000. Families, friends, coworkers, loved ones and community members are grieving for each person who has been lost to this disease. Reaching the milestone of 100, 000 persons lost in such a short timeframe is a sobering development and a heart-breaking reminder of the horrible toll of this unprecedented pandemic. COVID-19 has touched families in every part of America – with communities across the country experiencing the pandemic in different ways. As many communities are strategically reopening, it is important for everyone to work together to continue efforts to prevent community spread of COVID-19. We ask that all Americans continue to follow t...05-28-2020, 10:53 PM -
U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests| site |
(May 21, 2020) - - The U.S. Food and Drug Administration (FDA) published today (May 21, 2020) the following information:
Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on...05-26-2020, 12:09 AM -
U.S. Department of Labor Adopts Revised Enforcement Policies for Coronavirus| site |
(May 19, 2020) - - Today (May 19, 2020) the U.S. Department of Labor published the following information: WASHINGTON, DC – The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) has adopted revised policies for enforcing OSHA's requirements with respect to coronavirus as economies reopen in states throughout the country. Throughout the course of the pandemic, understanding about the transmission and prevention of infection has improved. The government and the private sector have taken rapid and evolving measures to slow the virus's spread, protect employees, and adapt to new ways of doing business. Now, as states begin reopening their economies, OSHA has issued two revised enforcement policies to ensure employers are taking action to protect their employees. First, OSHA is increasing in-person inspections at all types of workplaces. The ...05-22-2020, 03:54 AM -
Newsweek Article suggests that Coronavirus COVID-19 may have been Created with aid of U.S. Dollars | site |
Article says China lab received millions of U.S. Dollars for bat disease research
April 30, 2020 - - The publication Newsweek suggested in an April 28, 2020 article that the Coronavirus COVID-19 may have been created in a China lab in which the research was partially funded by millions of U.S. Dollars.
The article, titled, "Dr. Fauci Backed Controversial Wuhan Lab with Millions of U.S. Dollars" is located online at https://www.newsweek.com/dr-fauci-ba...search-1500741
or
Please press HERE...04-30-2020, 04:31 AM -
U.S. Securities and Exchange Commission Provides Temporary Additional Flexibility to Registered Investment Companies Affected by Coronavirus | site |
Permits Funds to Use Additional Funding and Other Tools to Manage their Portfolios for the Benefit of Investors
(March 23, 2020) - - Today (March 23, 2020), the U.S. Securities and Exchange Commission (SEC) published the following information: Washington D.C., March 23, 2020 —The Securities and Exchange Commission today announced temporary flexibility for registered funds affected by recent market events to borrow funds from certain affiliates and to enter into certain other lending arrangements. Today’s relief is designed to provide funds with additional tools to manage their portfolios for the benefit of all shareholders as investors may seek to rebalance their investments. “Today’s temporary action will provide an additional tool that funds can use to manage their portfolios for the bene...03-24-2020, 05:15 PM -
Coronavirus COVID-19 Update - - - FDA provides Update on Patient Access to certain REMS Drugs during COVID-19 Public Health Emergency | site |
(March 22, 2020) - - The U.S. Food and Drug Administration (FDA) published today (March 22, 2020) the following information:
Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.
“The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Under these circumstances, undergoing...03-23-2020, 10:36 PM -
Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators | site |
(March 22, 2020) - - The U.S. Food and Drug Administration (FDA) published today (March 22, 2020) the following information:
Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing. “The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar. “Today’s actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for. With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes ...03-23-2020, 10:14 PM -
Coronavirus COVID-19 Update - - - FDA Issues first Emergency Use Authorization for Point of Care Diagnostic | site |
(March 21, 2020) - - The U.S. Food and Drug Administration published today (March 21, 2020) the following information:
Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” said HHS Secretary Alex Azar. “With the development of point of care diagnostics, Americans who need tests will be able to ...03-23-2020, 09:48 PM -
Coronavirus COVID-19 Update - - - FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits | site |
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs
Judith A. McMeekin Pharm.D.
(March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
March 20, 2020
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs
Judith A. McMeekin Pharm.D.
The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention...03-23-2020, 08:54 PM -
Coronavirus COVID-19 Update - - - FDA Allows Expanded Use of Devices to Monitor Patients’ Vital Signs Remotely | site |
(March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.
“Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” said FDA...03-23-2020, 08:25 PM -
Coronavirus COVID-19 Update - - - FDA provides Guidance on Production of Alcohol-based Hand Sanitizer to help Boost Supply, Protect Public Health | site |
(March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
“We are aware of significant supply disruptions for alcohol-based hand sanitizers. Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply,” said FDA Commissioner...03-23-2020, 08:04 PM -
Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Development of Treatments | site |
(March 19, 2020) - - Today (March 19, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary. As part of those efforts, President Trump has directed the FDA to continue its work with the public and private sector to ensure the availability of potentially safe and effective life-saving drugs to patients who are in desperate need, including those infected with COVID-19. The FDA has been working closely with other gove...03-23-2020, 07:36 PM -
Study finds that New Coronavirus is stable for Hours on Surfaces| site |
SARS-CoV-2 stability similar to original SARS virus.
(March 17, 2020) - - Today (March 17, 2020), the National Institutes of Health (NIH) published the following information:
The virus that causes coronavirus disease 2019 (COVID-19) is stable for several hours to days in aerosols and on surfaces, according to a new study from National Institutes of Health, CDC, UCLA and Princeton University scientists in The New England Journal of Medicine. The scientists found that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detectable in aerosols for up to three hours, up to four hours on copper, up to 24 hours on cardboard and up to two to three days on plastic and stainless steel. The results provide key information about the stability of SARS-CoV-2, which causes COVID-19 disease, and suggests that people may acquire the virus through the air and...03-18-2020, 07:32 PM -
Federal Communications Commission Waives Rural Health Care and E-Rate Program Gift Rules to Promote Connectivity for Hospitals and Students during Coronavirus Pandemic| site |
Waiver Will Enable RHC and E-Rate Program Participants to Obtain Free Broadband Connections and Devices for Telehealth and Remote Learning During COVID-19 Outbreak
(March 18, 2020) - - Today, the Federal Communications Commission (FCC) released the following information: WASHINGTON, March 18, 2020—The Federal Communications Commission today announced important changes to the Rural Health Care (RHC) and E-Rate programs that will make it easier for broadband providers to support telehealth and remote learning efforts during the coronavirus pandemic. Specifically, the FCC’s Wireline Competition Bureau has waived the gift rules until September 30, 2020 to enable service providers to offer, and RHC and E-Rate program participants to solicit and accept, improved connections...03-18-2020, 05:46 PM -
SEC Staff Provides Guidance to Promote Continued Shareholder Engagement, Including at Virtual Annual Meetings, for Companies and Funds Affected by the Coronavirus Disease 2019 (COVID-19)| site |
(March 13, 2020) - - Today (March 13, 2020), the U.S. Securities and Exchange Commission (SEC) published the following information: Washington D.C., March 13, 2020 —The Securities and Exchange Commission today announced that the SEC staff has published guidance to assist public companies, investment companies, shareholders, and other market participants affected by COVID-19 with their upcoming annual shareholder meetings. The guidance is designed to facilitate the ability of companies to hold these important meetings, including through the use of technology, and engage with shareholders while complying with the federal securities laws. “The SEC staff recognizes that many public companies and other market participants are transitioning to teleworking, virtual me...03-18-2020, 03:08 PM -
HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections| site |
(March 18, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information: In response to the now global pandemic, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), continues to work with its public-private partners to find solutions to mitigate the public health impact of the coronavirus disease 2019 (COVID-19). Part of this landscape is the immediate need for diagnostics tests that can quickly and accurately diagnose COVID-19 infections in order to identify the virus and mitigate the spread of the disease. BARDA will provide Mesa Biotech, Inc. of San Diego, California, with technical expertise and $561,330 in immediate funding to pursue eventual Food and Drug Administration (FDA) approval or clearance of its dia...03-18-2020, 02:47 PM -
Statement from Secretary Steven T. Mnuchin Regarding House-passed Coronavirus Response Legislation| site |
(March 16, 2020) - - On March 14, 2020 the U.S. Department of the Treasury published the following Statement from Secretary Steven T. Mnuchin Regarding House-passed Coronavirus Response Legislation:
“This bill will provide significant relief to small businesses that cannot afford the employee costs associated with coronavirus. The bill provides a dollar for dollar reimbursement for coronavirus related sick leave costs. To protect businesses concerned about cash flow, the Treasury will use its regulatory authority to advance funds to employers in a number of ways. Employers will be able to use cash deposited with the IRS to pay sick leave wages. Additionally, for businesses that would not have sufficient taxes to draw from, Treasury will use its regulatory authority to make advances to small businesses to cover such costs.”...03-16-2020, 04:41 AM -
Agencies encourage Financial Institutions to meet Financial Needs of Customers and Members affected by Coronavirus| site |
Board of Governors of the Federal Reserve System
Consumer Financial Protection Bureau
Federal Deposit Insurance Corporation
National Credit Union Administration
Office of the Comptroller of the Currency
Conference of State Bank Supervisors (March 9, 2020) - - Today, the Board of Governors of the Federal Reserve System published the following information contained in a joint press release apparently issued by the agencies italicized above: Federal financial institution regulators and state regulators today encouraged financial institutions to meet the financial needs of customers and members affected by the coronavirus. The agencies recognize the potential impact of the coronavirus on the customers, members, and operations of many financial institutions and will provide appropriate regulatory assistance to affe...03-10-2020, 12:51 AM -
Red Cross Coronavirus Safety and Readiness Tips for You | site |
(March 9, 2020) - - On March 5, 2020 the Red Cross published the following Coronavirus Safety and Readiness Tips for You:
The American Red Cross is closely monitoring the evolving outbreak of Coronavirus Disease 2019 (COVID-19), as well as following the latest guidance from the Centers for Disease Control (CDC).
We know this is a stressful time and people want to know what they can do right now to protect themselves and their families. That’s why the Red Cross is highlighting some everyday health safety and preparedness steps that people in the U.S. can take now in response to coronavirus concerns.
LIMIT THE SPREAD OF GERMS AND PREVENT INFECTION
There are common sense steps we can all take to prevent the spread of any respiratory virus:- Avoid close contact
03-09-2020, 08:50 AM -
Amtrak Statement: Coronavirus Update, 2:00 p.m. CT, Mar. 8.| site |
(March 9, 2020) - - On March 8, 2020 Amtrak published the following information:
Amtrak Statement: Coronavirus Update, 2:00 p.m. CT, Mar. 8.
At Amtrak, safety is our top priority. We have received notification from St. Louis County, Mo. that an individual who traveled on Amtrak train 303 (Chicago – St. Louis) on March 4, 2020, has tested presumptive positive for the coronavirus. We are working in close contact with public health and emergency management teams to have the best available information to be able to share with our customers and employees who might be affected. Amtrak is notifying passengers and employees who may have been on the same train, and as a precaution, we have taken the train out of service for comprehensive cleaning and disinfection, and are also working to do a thorough disinfection of the Chicago and St. Louis stations. For more in...03-09-2020, 07:52 AM -
Federal Communications Commission Announces Preventive Measures Related To Coronavirus| site |
(March 4, 2020) - - On March 4, 2020 the Federal Communications Commission (FCC) released a Public Notice titled, "FCC Announces Preventive Measures Related To Coronavirus".
The Public Notice may be viewed at https://docs.fcc.gov/public/attachme...C-362836A1.pdf
or
Press here: | Docx | pdf | txt |...03-09-2020, 07:05 AM -
U.S. Department of Health and Human Services Solicits Proposals for Development of Medical Products for Novel Coronavirus| site |
(March 6, 2020) - - Today, the U.S. Department of Health and Human Services published the following information:
As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat coronavirus infections.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to solicit proposals for advanced development and licensure of COVID-19 diagnostics, vaccines, or medicines such as therapeutics or antivirals. “Amid the expanding global outbreak of COVID-19, Americans n...03-07-2020, 10:19 PM -
Coronavirus update: World Health Organization Chief calls for Private Sector to Step Up, and, should You take that Flight? | site |
(March 6, 2020) - - On March 6, 2020 the United Nations (UN) published the following information:
In his daily briefing to the press on Friday, World Health Organization (WHO) chief, Tedros Adhanom Ghebreyesus, warned that supplies of medicine are at risk of disruption due to the epidemic, given that China - the worst hit nation so far - is a major producer of pharmaceutical ingredients. So far, no imminent specific shortages have been identified, and manufacturing has resumed in most parts of China, but the private sector needs to be involved, to ensure that countries can access life-saving products, said Tedros. “You’ve heard me talk about the market failure for personal protective equipment. We look forward to businesses stepping up to play their part. We need you”. The WHO chief anno...03-07-2020, 01:15 AM -
United Nations Coronavirus update: 290 Million Students now Stuck at Home| site |
(March 5, 2020) - - Today (Thursday, March 5, 2020) the United Nations (UN) published the following information:
School closures in 13 countries linked to the COVID-19 virus epidemic have disrupted the education of more than 290 million students, a record number, the UN education agency UNESCO said on Thursday.
Disadvantaged children are the worst-hit by the emergency measures, declared UNESCO Director-General Audrey Azoulay: “While temporary school closures as a result of health and other crises are not new, unfortunately, the global scale and speed of the current educational disruption is unparalleled and, if prolonged, could threaten the right to education.” A further nine countries have implemented localized school closures: UNESCO estimates that, if these countries close schools nat...03-06-2020, 06:54 PM -
American Federation of Teachers and UNITE HERE Call on Federal Government to Introduce Paid Sick Leave and Release Comprehensive Health, Safety and Economic Plan to Fight Coronavirus| site |
(March 5, 2020) - - Today, the American Federation of Teachers (AFT) published the following information: WASHINGTON—In the wake of the continued spread of the coronavirus in the U.S., the American Federation of Teachers and UNITE HERE—which together represent educators, healthcare professionals, public employees, hotel, food service, airport, warehouse and casino workers across the country—are calling on the federal government to issue clear national guidance and take decisive action to support these workers and the people they care for, including, among other things, a national policy on paid sick time. UNITE HERE President D. Taylor said: “It is in our national interest that our leaders take decisive action to protect America’s workers and the general public toda...03-06-2020, 02:39 AM -
American Hotel & Lodging Association Joins Business Leaders to Discuss Response to Coronavirus| site |
(March 4, 2020) - - Today, the American Hotel & Lodging Association published the following information: WASHINGTON (March 4, 2020) – Chip Rogers, president and CEO of the American Hotel & Lodging Association (AHLA), today joined leaders from the U.S. Chamber of Commerce, U.S. Travel Association, Airlines for America, and the National Retail Federation to discuss the potential impact of COVID-19 and the business community is responding. Rogers underscored the hotel industry’s commitment to the health and safety of our employees and guests, and encouraged travelers to follow CDC guidance on COVID-19 while recognizing that domestic travel is still possible. “I want to reiterate how critically important the health and safety of our guests and employees is to us as an association and to each and every one of our members,” said Rogers. “As someone who is o...03-05-2020, 05:23 PM -
UN estimates that Coronavirus COVID-19 wipes 50 Billion Dollars off Global Exports in February alone, as IMF pledges Support for Vulnerable Nations| site |
(March 4, 2020) - - Today (March 4, 2020), the United Nations (UN) published the following information:
The extent of the damage to the global economy caused by novel coronavirus COVID-19 moved further into focus on Wednesday as UN economists announced a likely $50 billion drop in worldwide manufacturing exports in February alone.
In remarks made at a joint press conference with the head of the World Bank Group, the IMF Managing Director, Kristalina Georgieva, said that the UN-backed global funds would make up the shortfall, in effect, by offering to inject around $50 billion into low-income and emerging market nations, pending requests for support. "Thanks to the generosity of our shareholders, we have about $1 trillion in overall lending cap...03-05-2020, 04:33 PM -
Centers for Medicare and Medicaid Services Announces Actions to Address Spread of Coronavirus| site |
CMS calls on all health care providers to activate infection control practices and issues guidance to inspectors as they inspect facilities affected by Coronavirus
(March 4, 2020) - - Today, the Centers for Medicare and Medicaid Services published the following information: Today, the Centers for Medicare & Medicaid Services (CMS) is announcing several actions aimed at limiting the spread of the Novel Coronavirus 2019 (COVID-19). Specifically, CMS is issuing a call to action to health care providers across the country to ensure they are implementing their infection control procedures, which they are required to maintain at all times. Additionally, CMS is announcing that, effective immediately and, until further notice, State Survey Agencies and Accrediting Organizations will focus their facility inspections...03-05-2020, 03:17 AM -
U.S. Postal Service Statement on Coronavirus| site |
(February 28, 2020) - - Today (February 28, 2020), the U.S. Postal Service (USPS) issued the following statement on Coronavirus:
The U.S. Postal Service continues to have a temporary suspension of the guarantee on Priority Mail Express International destined for China and Hong Kong, which has been effective since Monday, Feb. 10, 2020, due to widespread airline cancellations and restrictions into this area. In addition, customers may see delays in mail and packages destined to China as well as from China. The Postal Service is undertaking all reasonable measures to minimize the impact to our customers.
The Postal Service is closely monitoring the coronavirus situation and has been in contact with other U.S. Government agencies. The Centers for Disease Control and Prevention (CDC) has information available on its website, https://www.cdc.gov , that provides the latest information about...03-04-2020, 03:46 AM -
Red Cross Media Statement on 2019 Novel Coronavirus| site |
(March 2, 2020) - - Today (March 2, 2020), the American Red Cross provided the following Media Statement on 2019 Novel Coronavirus: The American Red Cross is closely monitoring the rapidly evolving outbreak of coronavirus disease 2019, COVID-19, and preparing to carry out our live-saving mission in the event of any possible disruptions. The American Red Cross is also supporting government agencies to assist evacuees who have been quarantined after returning to the U.S. from overseas. When requested, our role is to provide blankets, comfort kits, snacks, stuffed animals and other support items. We will continue to work with U.S. officials and partners to determine what support may be needed in the coming days and weeks as the situation continues to evolve. In particular, we will continue to collaborate with AABB, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention ...03-04-2020, 03:21 AM -
Coronavirus (COVID-19) Update: FDA and CDC take Action to Increase Access to Respirators, including N95s, for Health Care Personnel| site |
(March 2, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:
Today, in a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.
“President Trump has made...03-03-2020, 12:05 AM -
UN Releases US$15 Million to Help Vulnerable Countries Battle the Spread of the Coronavirus| site |
(March 2, 2020) - - On March 1, 2020 the World Health Organization (WHO) published the following information: UN Humanitarian Chief Mark Lowcock today released US$15 million from the Central Emergency Response Fund (CERF) to help fund global efforts to contain the COVID-19 virus. The announcement came as the World Health Organization (WHO) upgraded the global risk of the coronavirus outbreak to "very high" – its top level of risk assessment. The WHO has said there is still a chance of containing the virus if its chain of transmission is broken. The sudden increases of cases in Italy, the Islamic Republic of Iran and the Republic of Korea are deeply concerning. There are now cases linked to Iran in Bahrain, Iraq, Kuwait and Oman, along with cases linked to Italy in Algeria, Austria, Croatia, Germany, Spain and Switzerland. The UN funding has been released to t...03-02-2020, 10:23 PM -
World Health Organization releases Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19)| site |
(February 28, 2020) - - Today, the World Health Organization (WHO) made public the Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19).
In releasing the report, WHO said the following:
"Here is the report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19), published as received from the mission, unabridged by WHO"
The report may be viewed at https://www.who.int/docs/default-sou...nal-report.pdf...
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Press HERE02-29-2020, 12:42 AM -
World Health Organization Online Training as a Weapon to Fight the New Coronavirus| site |
(February 7, 2020) - - Today (February 7, 2020), the World Health Organization (WHO) published the following information:
More than 25 000 people across the globe have accessed real-time knowledge from WHO experts on how to detect, prevent, respond to and control the new coronavirus in the 10 days since the launch of an open online training.
The learning team of the WHO Health Emergencies Programme worked with technical experts to quickly develop and publish the online course on 26 January – 4 days before the 2019-nCoV outbreak was declared a public health emergency of international concern. Approximately 3000 new users have registered for the training every day since its launch, demonstrating the high level of interest in the virus among health professionals and the general public. In addition, more than 200 000 people have viewed the ...02-28-2020, 03:18 PM