For Industry

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.

Page Last Updated: 11/18/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English