Rosanne Chandra and Ankit Ghodasara, CDER Office of Generic Drugs, provide a brief overview of common deficiencies found during the filing review and recommends best practices for submitting a substantially complete ANDA.

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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

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