FDA discusses the most common labeling mistakes found in Abbreviated New Drug Applications (ANDAs) and how to avoid them. FDA will also provide answers to common labeling questions asked by generic drug applicants.
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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
