Lexology December 6, 2024
Akin Gump Strauss Hauer & Feld LLP

On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat serious conditions for which there is an unmet need, and for which the sponsor is seeking accelerated approval. In particular, the guidance details the conditions for confirmatory study...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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