Drug Information Update - FDA posts draft guidances describing GDUFA performance metrics and associated webinars

FDA Division of Drug Information: Know the Moment It Happens

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.

FDA published notices in the Federal Register announcing the availability of two draft guidances for industry:

These draft guidances are intended to assist applicants preparing to submit amendments to ANDAs, prior approval supplements, and amendments to prior approval supplements under the Federal Food, Drug, and Cosmetic Act, by explaining how the GDUFA performance metrics apply to these submissions.

Pre-recorded webinars explaining these guidances are available at:

Submit electronic comments on the draft guidances to www.regulations.gov

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