ICH Q12 Guidance and Emerging Technology Program (11of16) Generic Drugs Forum 2020

Ashley Boam and Thomas O’Connor from CDER’s Office of Pharmaceutical Quality discuss ICH Q12 as it applies to generic drugs and CDER’s emerging technology program.

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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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