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FDA GUIDANCE · FINALOctober 17, 2024

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
User Fees, Chemistry, Manufacturing, and Controls (CMC), Generic Drugs, Pharmaceutical Quality, Drug Competition Action Plan
Issue date
October 17, 2024
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