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FDA (CDER)
GUIDANCE FINAL
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
Published: 9/11/2025Detected: 3/20/2026

Summary preview

Clarifies how FDA may assess drug manufacturing facilities proposed in pending applications when the usual manufacturing-inspection pathway is constrained, using alternative tools and risk-based decision-making.

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manufacturing
quality
#FDA inspection
#manufacturing facility
#pending applications
#CMC
#GMP

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