FDA Announces Open Registration for Public Meeting on Reauthorizing the Generic Drug User Fee Amendments (GDUFA) On November 16, 2021, the U.S. Food and Drug Administration will hold a virtual public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2023 through 2027 (GDUFA III). GDUFA authorizes FDA to assess and collect user fees to support human generic drug activities. The current GDUFA authorization expires in September 2022. The purpose of this virtual public meeting is to provide interested stakeholders an opportunity to learn about and share their views on proposed recommendations for the program's reauthorization. The GDUFA III meeting agenda will include presentations by FDA staff and panels representing various stakeholder groups that summarize the negotiated enhancements. The agency will accept public comments on those enhancements through December 12, 2021 by submission to the open docket, which will be published prior to the public meeting. Registration to attend this virtual public meeting is voluntary and will allow registrants to receive updates when new information or additional materials are available. If you wish to present during the public comment session, please submit your request to GenericDrugPolicy@fda.hhs.gov by 11:59 PM (ET) on November 8, 2021. The meeting's agenda, additional materials, and any other updates will be posted to FDA's website as they become available. | 
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