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Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4of39) Complex Generics 2018
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Suneela Prodduturi from CDER’s Office of Pharmaceutical Quality covers an overview of OPQ and the OPQ pre-ANDA process.
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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.
Phone: (301) 796-6707 I (866) 405-5367
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone: (301) 796-6707 I (866) 405-5367
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