ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017

Martha Nguyen and Maarika Kimbrell, CDER Office of Generic Drugs, discuss common policy and regulatory challenges that may be encountered during the R&D/Pre-filing phase. They cover challenges such as the identification of RLD/Reference Standard/Basis of Submission, suitability petitions, 505b(2) appropriateness, unavailable RLD, RLD labeling, and other common issues FDA sees as important to relay to applicants developing ANDAs. _______________________________
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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