FDA GUIDANCE · FINALJune 16, 2025

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

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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

Chemistry, Manufacturing, and Controls (CMC), Generic Drugs, Pharmaceutical Quality

Issue date

June 16, 2025

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