Pre-ANDA Logistics and Best Practices (27of39) Complex Generics 2018

Robert Berendt, CDER Office of Pharmaceutical Quality (OPQ), shares common deficiencies and OPQ considerations.
Ying Fan, CDER Office of Generic Drugs (OGD), shares common deficiencies and OGD considerations.
Stella Grosser, CDER Office of Translational Sciences, shares common deficiencies – statistical considerations.

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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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