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FDA GUIDANCE · FINALOctober 16, 2024

Requests for Reconsideration at the Division Level 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, Generic Drugs
Issue date
October 16, 2024
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