FDA Review posts product approval summaries for the week ending 3/5/2022.
FDA declines to grant Ocugen an emergency use authorization for Covaxin for active immunization to prevent Covid-19 in individuals aged two to 18 year...
Federal Register notice: FDA issues an order to debar Patrick Charles Bishop for a period of five years from importing or offering for import any drug...
Sanofi petitions FDA to mandate a labeling change to Seqirus influenza vaccine products Fluad and Fluad Quadrivalent to reflect that a confirmatory st...
A CDER online post updates the Centers efforts to support rare disease drug development, particularly through data sharing initiatives that are import...
FDA issues South Korea-based GC Pharma a complete response letter on its BLA for GC5107 (immune globulin intravenous (human), 10% Liquid) because the ...
Federal Register notice: FDA makes available a final guidance entitled Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.
Federal Register notice: FDA debars George Kuiper for a period of five years from importing or offering for import any drug into the U.S. due to felon...