B.J. Ryan, CDER Office of Pharmaceutical Quality, provides the audience a better understanding of the risk and science-based evaluation for facilities named in applications. He shares an overview of the review approach and discusses of pre-approval inspections.
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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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Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
