Submit proposed questions on this poster to DMFWorkshop2021@fda.hhs.gov by March 19, 2021, and tune in for the subsequent panel discussion during the Drug Master File (DMF) and Drug Substance follow-up webinar on April 9, 2021.
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This poster discusses alignment of the DMF review process with the ANDA review process and timelines.

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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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