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USP Pending Monograph Process and USP compliance for Industry

Submit questions on this poster to by Feb. 15, and hear questions discussed at the Drug Master File (DMF) and Drug Substance Workshop on Mar. 3-4, 2021.
This poster discusses FDA’s current thinking on the USP-PMP and recommendations for drug master file (DMF) holders.
To review all posters and for conference information, visit:
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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Phone – (301) 796-6707 I (866) 405-5367

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