The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled...
Read moreFDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section...
Read moreU.S. Food and Drug Administration issued a final guidance, Bispecific Antibody Development Programs. This final guidance provides...
Read moreOn May 19, 2021, the FDA finalized the guidance for industry entitled “ANDAs for Certain Highly...
Read moreOn May 20, 2021, the FDA issued final guidance for industry (GFI) #171 entitled “Demonstrating Bioequivalence...
Read moreFDA Revises Guidance to Provide Clarification on Actions FDA May Take on an Application When the...
Read moreU.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12...
Read moreOn May 11, 2021, the FDA published the guidance for industry entitled “M9 Biopharmaceutics Classification System-Based...
Read morethe U.S. Food and Drug Administration issued a new report titled, "Resiliency Roadmap for FDA Inspectional...
Read moreFDA is issuing this guidance to describe how we will request and conduct voluntary remote interactive...
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