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277 articles found
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Coronavirus (COVID-19) Update: May 4, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA Center for Drug Evaluation and Research (CDER) continu... -
Coronavirus (COVID-19) Update: April 30, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On April 28, the FDA approved an abbreviated new drug applicat...
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Coronavirus (COVID-19) Update: April 27, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, the agency i...
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FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety ReviewFollowing a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and...
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Coronavirus (COVID-19) Update: April 23, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the agency’s regulatory processes for reviewing all...
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FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 VaccinesThe U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure th...
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Coronavirus (COVID-19) Update: April 20, 2021The 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 took steps to further facilitate the authorizat...
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Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody BamlanivimabToday, 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...
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Coronavirus (COVID-19) Update: April 16, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, the agency i...
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FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities th...