Rachel Goehe and Katherine Won from CDER’s Office of Generic Drugs, Office of Labeling Review provide an overview of the labeling review process. They also cover supply recommendations, guidance for ensuring high-quality labeling submissions, strategies to reduce the number of review cycles, and responses to most frequently asked labeling-related questions.

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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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