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FDA commissioner to speak at public meeting on GDUFA reauthorization


The 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 2017 for fiscal years 2023 through 2027 — dubbed GDUFA III — on July 21, 2020, from 9 a.m. to 3 p.m.,

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 review and approval of safe and effective high-quality generic drugs. FDA’s current GDUFA authorization expires in September 2022.

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 public meeting agenda will include a keynote address by FDA Commissioner Stephen Hahn, presentations by FDA staff and stakeholder groups, as well as time allotted for public comment. Written public comments will be accepted through August 20 via submission to Docket No. FDA-2020-N-1459.

Information about the current program, including the GDUFA II commitment letter that details current agency performance goals, is available here.

To register click here.

Registrants will receive instructions to access the live webcast of the virtual meeting. The webcast information, additional materials, and any other updates will be posted to FDA’s GDUFA website as they become available.

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