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USP Pending Monograph Process and USP compliance for Industry

Submit questions on this poster to DMFWorkshop2021@fda.hhs.gov 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: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-workshop-03032021-03042021
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training – https://www.fda.gov/cdersbia
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist – https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources – https://www.fda.gov/cderbsbialearn
Twitter – https://twitter.com/FDA_Drug_Info
Email – CDERSBIA@fda.hhs.gov
Phone – (301) 796-6707 I (866) 405-5367

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