Tag Archives: EUA

COVID-19: When will FDA convene a public meeting of its Antimicrobial Drugs Advisory Committee for monoclonal antibody EUA requests?

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By Daniel R. Lucey M.D., MPH, FIDSA On Oct. 7, the U.S. Food and Drug Administration received requests for Emergency Use Authorization for monoclonal antibodies from two companies (Regeneron and Eli Lilly), but has not yet announced any public meetings of its Antimicrobial Drugs Advisory Committee to advise on either general issues or specific requests […]

COVID-19: FDA Emergency Use Authorization for a vaccine in the fall of 2020 means the time for public dialogue is August      

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By Daniel R. Lucey M.D., MPH, FIDSA The only past U.S. Food and Drug Administration Emergency Use Authorization for any vaccine was in January 2005 for the licensed (since 1970) anthrax vaccine to be used in military personnel “for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed […]