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105 articles found
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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... -
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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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 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...
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Coronavirus (COVID-19) Update: April 13, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As the FDA celebrates National Minority Health Month, we’re wo...
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Joint CDC and FDA Statement on Johnson & Johnson COVID-19 VaccineAs of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and...
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Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses AvailableToday, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses...
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FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple MyelomaThe U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has...
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Coronavirus (COVID-19) Update: March 19, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On March 16, the FDA posted a new web page on FDA.gov, Screeni...