← FDA GUIDANCE
FDA GUIDANCE · FINALSeptember 11, 2025

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

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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
Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Issue date
September 11, 2025
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