The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
GDUFA Federal Register Notices
FDA has issued a number of documents to answer anticipated questions from industry about the program’s requirements and details regarding implementation. These documents also highlight preparatory steps human generic drug manufacturers will need to complete to be in compliance with this new legislation.
The materials available include:
- Guidance for Industry, Generic Drug User Fee Amendments: Questions and Answers - Federal Register Notice of Public Meeting on Generic Drug User Fee Amendments - Federal Register Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations - Federal Register Notice on Agency Information Collection Activities For more information please visit: GDUFA Federal Register Notices
- Guidance for Industry, Self-Identification of Generic Drug Facilities, Sites and Organizations
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- For additional drug information, please visit the DDI Web page.
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