Drug Substance Facilities – Hidden and Critical Intermediate

FDA covers critical intermediates and how to avoid DMF hidden facilities in order to prevent delays in referencing application approvals.
Presenter:
Wei Liu, Division of Lifecycle API, and Cassandra Abellard, Division of Pharmaceutical Manufacturing in the Office of Pharmaceutical Manufacturing Assessment (OPMA)

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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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