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FDA Biologics (BLA & Biosimilars)
Original article

Phase 1 IND Chemistry, Manufacturing, and Controls Flexibilities

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Summary

FDA published information on Chemistry, Manufacturing, and Controls (CMC) regulatory flexibilities applicable to Phase 1 Investigational New Drug (IND) applications.

Importance:2/10
Sentiment:
0.00
CMCChemistry Manufacturing ControlsPhase 1 INDRegulatory GuidanceFDA Flexibilities

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Published by FDA Biologics (BLA & Biosimilars) on September 3, 2026 1:58 PM

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