CDER Office of Generic Drugs’ Andrew Kim and Office of Pharmaceutical Quality’s Craig Kiester provide an overview and tips on how to make mid-cycle assessment meetings and post-complete response letter meetings successful. They discuss the mid-review-cycle meeting (MRCM) goals and industry responsibilities and post-complete response letter meeting request (CRL MR) tips.
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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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