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

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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

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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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Federal Emergency Management Agency Supports Vaccine Distribution: COVID-19 Response Update | site |



(Information contained in Federal Emergency Management Agency [FEMA] press release dated: March 2, 2021)

Washington - - FEMA continues its push to speed up vaccinations across the country, supporting states as they open additional community vaccination centers this week. In addition to Pfizer and Moderna, the Johnson & Johnson vaccine will be delivered to three federal pilot community vaccination centers in California, Florida and Texas, helping to bring this unprecedented pandemic to an end. FEMA continues increasing vaccine allocations to states, tribes and territories, ensuring everyone who wants a vaccine can get one. Using data from CDC’s social vulnerability index, the agency is partnering with state leaders to identify community vaccination centers where they will be able to do the most good for the most vulnerable populations. Today, a comm...

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

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Listeria Outbreak Update: CDC Warning| site |



(Information contained in Centers for Disease Control and Prevention [CDC] press release dated: February 24, 2021)

CDC has updated its food safety alert for a Listeria outbreak linked to queso fresco made by El Abuelito Cheese Inc.: https://www.cdc.gov/listeria/outbrea...-21/index.html

Key points:

• CDC has expanded its advice to not eat, sell, or serve any cheese sold under the brand name El Abuelito, in addition to recalled queso fresco cheese sold under the brand names of El Abuelito, Rio Grande, and Rio Lindo. CDC is concerned that any cheese made or handled at this facility could be contaminated and make people sick.

• Three new illnesses were reported this week. This outbreak has sickened a total of 10 people in four states (Connecticut, Maryland, New York, and Virginia).

• Nine people have been hospitalized. No deaths have been reported.

• Interviews with sick people

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Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | site |



Suite of Guidances Addresses Vaccines, Diagnostics and Therapeutics


(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 22, 2021) Today, the U.S. Food and Drug Administration 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 is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, M.D. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the ...

Audio Recording of Centers for Disease Control and Prevention February 12, 2021 Update on COVID-19 | site |




(Audio recorded information contained in Centers for Disease Control and Prevention (CDC) press release dated: February 12, 2021)



Note: This version of the audio recording may contain an initial 35 minutes and 16 seconds of music. If music is heard, please move the progress bar to the 35 minutes and 17 seconds point.

Also, there may be an audio gap from the 53 minutes and 47 seconds point to the 54 minutes and 25 seconds point.

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Source and credit: Centers...

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

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FACT SHEET: Update on USDA Activities to Contain the COVID-19 Pandemic | site |




USDA Deploys 127 Disaster, Public Health Specialists to Assist with Federal Response


(Information contained in U.S. Department of Agriculture [USDA] press release dated: February 10, 2021)


Washington, Feb. 10, 2021 — In January 2021, President Biden released the National Strategy for the COVID-19 Response and Pandemic Preparedness. The plan is driven by science, data, and public health to improve the effectiveness of our nation’s fight against COVID-19 and to restore trust, accountability and a sense of common purpose in our response to the pandemic.

The National Strategy provides a roadmap to guide America out of the worst public health crisis in a century. It is organized around seven goals:

1. Restore trust with the American people.
2. Mount a safe, effective, and comprehensive vaccination campaign.
3. Mitigate spread through

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FEMA Supports Vaccine Distribution: COVID-19 Response Update | site |



(Information contained in Federal Emergency Management Agency [FEMA] press release dated: February 9, 2021)

Washington - - FEMA has now provided more than $3.15 billion to states, tribes, territories and the District of Columbia for expenses related to COVID-19 vaccination at 100% federal cost share and deployed 752 incident management and 317 incident support staff across the nation to support vaccine centers with federal personnel and technical assistance. Additional FEMA staff across the country are supporting virtually. FEMA is supporting vaccination centers by providing expedited financial assistance, federal equipment and supplies, and deploying federal personnel to states, tribes, territories and other eligible applicants for vaccination efforts. This assistance is processed when a request is submitted. As the number of states with obligations increases, ...

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...

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

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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

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FEMA Supports Vaccine Distribution: COVID-19 Response Update | site |



(Information contained in Federal Emergency Management Agency [FEMA] press release dated: February 1, 2021)

Washington - - FEMA has now obligated more than $1.7 billion to states, tribes and territories, and Washington, D.C., for vaccination sites and deployed more than 300 staff to 10 states and one territory to support vaccination centers with personnel and technical assistance. Additional staff across the country are supporting virtually. In the last 48 hours, the following obligations over $1 million were made:

• $51.6 million to Alabama.
• $5.9 million to California.
• $245 million to Florida.
• $104.6 million to Georgia.
• $46.9 million to Kentucky.
• $15 million to Minnesota.
• $32 million to Mississippi.
• $103 million to North Carolina.
• $2.5 million to South Carolina.
• $68.5 million to Tennessee.
• $3.2 million to Virginia.
• $47 million to Wisconsin.

As of Jan....