What Constitutes Complex Drug-Device Combination (18of35) Complex Generics – Sep. 25-26, 2019

Lisa Bercu, Regulatory Counsel in the Office of Generic Drugs, shares a general Framework for ANDAs, combination products, primary mode of action (PMOA), and user interface.

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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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