FDA GUIDANCE · FINALAugust 20, 2024

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry

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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

Drug Competition Action Plan, Generic Drugs

Issue date

August 20, 2024

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