FDA discusses critical pathways, modes, types, and timing of communications during the DMF and application lifecycle along with advice and best practices from an FDA perspective on maximizing the effectiveness of these communications.
Presenters:
David Skanchy, Director, Division of Lifecycle API, Office of New Drug Products, Office of Pharmaceutical Quality
Benjamin Danso, Office of Program and Regulatory Operations (OPRO), Office of Pharmaceutical Quality
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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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