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Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15of27) Generic Drugs Forum 2018
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CDER Office of Generic Drugs’ Regulatory Filing Reviewers Bijal Patel and Mavis Mbi discuss Refuse-to-Receive (RTR) statistics, common RTR deficiencies, communications, and resources.
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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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