FDA announces public meeting to gather stakeholder input on GDUFA reauthorization | FDA

Generic Drug User Fee Amendments | FDA





FDA announces public meeting to gather stakeholder input on GDUFA reauthorization

On July 21, 2020, the U.S. Food and Drug Administration will hold a virtual public meeting to request public input on the reauthorization of the Generic Drug User Fee Amendments of 2012 for fiscal years 2023 through 2027 (GDUFA III). GDUFA authorizes FDA to collect user fees, which support the review of generic human drug applications and creates a reliable funding source important to the agency’s continued ability to ensure timely approval of safe and effective high-quality generic drugs. FDA’s current GDUFA authorization (“GDUFA II”) expires at the end of fiscal year 2022 (in September 2022). Information about the current program, including the GDUFA II commitment letter that details current agency performance goals, is available on FDA’s GDUFA website.

The purpose of this virtual public meeting is to allow interested stakeholders an opportunity to provide their views on the program’s reauthorization. The GDUFA III meeting agenda will include presentations by FDA staff and stakeholder groups, as well as time allotted for public comment and discussion. Public comments will be accepted through August 20, 2020 by submission to docket No. FDA-2020-N-1459, which will be published prior to the public meeting.

To attend this meeting, please register by July 7, 2020. Registrants will receive instructions to access the live webcast of the virtual meeting. The meeting’s agenda, webcast information, additional materials, and any other updates will be posted to FDA’s GDUFA website as they become available.

Register