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Pre-ANDA Program Update and Tips for Success – OPQ Perspective
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Fang Yuan, PhD, Office of Lifecycle Drug Products, discusses GDUFA-II pre-ANDA metrics and recommendations to prepare pre-ANDA development and submission meeting requests.
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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
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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
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