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  1. Generic Drug User Fee Amendments

GDUFA Reauthorization Negotiation Sessions

In accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) held negotiations with the generic drug industry on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA) program. The FDA publishes all negotiation meeting minutes on this website.

FDA-Industry Negotiations Meeting Minutes

Fee Modeling Subgroup

FDA-Industry Small Business Subgroup Meeting Minutes

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