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  • FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers

    U.S. Food and Drug Administration Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: August 5, 2021)


    The following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition

    “The FDA is committed to ensuring that food containers are safe for consumers. We are encouraging manufacturers and distributors to consult with us regarding the regulatory status of any manufacturing processes used to produce fluorinated polyethylene containers for use in contact with food.

    We issued this letter out of an abundance of caution to remind industry that only certain fluorinated containers may be used in contact with food. It is important to note that there is no evidence of unlawful manufacturing
    ...
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  • FDA Approves First Oral Blood Thinning Medication for Children

    FDA Approves First Oral Blood Thinning Medication for Children

    U.S. Food and Drug Administration Approves First Oral Blood Thinning Medication for Children | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: June 21, 2021) Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to preve...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
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  • 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
    ...
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  • Excerpt of FDA Coronavirus COVID-19 Update - - - March 12, 2021

    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 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
    ...
    See more | Go to post

  • 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...
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  • FDA Coronavirus COVID-19 Update - - - March 5, 2021

    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
    ...
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  • 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. ...
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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...
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  • FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

    FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

    U.S. Food and Drug Administration Issues Emergency Use Authorization for Third COVID-19 Vaccine | site |



    FDA says "Action Advances Fight Against COVID-19, Follows Comprehensive Evaluation of Available Safety, Effectiveness and Manufacturing Quality Information by FDA Career Scientists, Input from External Experts"


    (Information contained in U.S. Food and Drug Administration [FDA] press released dated: February 27, 2021) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against...
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  • 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)....
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  • Coronavirus COVID-19 Update - - - FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

    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 ...
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  • FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

    FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

    U.S. Food and Drug Administration Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy | site |



    Drug Is Given Before Chemotherapy to Protect Bone Marrow Function


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 12, 2021) Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme. “For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time an...
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  • 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
    ...
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  • FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate

    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 4, 2021)

    The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. “A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA remains committed t...
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  • Staff Reporter 1
    FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers
    by Staff Reporter 1
    U.S. Food and Drug Administration Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: August 5, 2021)


    The following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition

    “The FDA is committed to ensuring that food containers are safe for consumers. We are encouraging manufacturers and distributors to consult with us regarding the regulatory status of any manufacturing processes used to produce fluorinated polyethylene containers for use in contact with food.

    We issued this letter out of an abundance of caution to remind industry that only certain fluorinated containers may be used in contact with food. It is important to note that there is no evidence of unlawful manufacturing
    ...
    08-15-2021, 03:08 AM
  • Staff Reporter 1
    FDA Approves First Oral Blood Thinning Medication for Children
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves First Oral Blood Thinning Medication for Children | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: June 21, 2021) Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to preve...
    06-22-2021, 09:08 AM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
    04-18-2021, 04:36 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs
    by Staff Reporter 1
    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
    ...
    03-23-2021, 12:14 AM
  • Staff Reporter 1
    Excerpt of FDA Coronavirus COVID-19 Update - - - March 12, 2021
    by Staff Reporter 1
    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 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, 10:40 PM

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