|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA announces open registration for public meeting on reauthorizing the Prescription Drug User Fee Act (PDUFA) On September 28, 2021, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act for fiscal years 2023 through 2027 ("PDUFA VII"). PDUFA authorizes FDA to collect user fees which supports the process for the review of human drugs and creates a reliable funding source that is important to the agency's continued ability to ensure timely review of the safety and effectiveness of new medications. FDA's current PDUFA authorization ("PDUFA VI") expires in September 2022. The purpose of this virtual public meeting is to allow interested stakeholders an opportunity to provide their views on recommended enhancements to the program's reauthorization. The PDUFA VII meeting agenda will include presentations by FDA staff and industry that summarize the negotiated and agreed-upon enhancements. Public comments on those enhancements will be accepted through October 28, 2021 by submission to docket No. FDA-2021-N-0891, which will be published prior to the public meeting. Registration to attend this virtual public meeting is voluntary but will allow registrants to receive updates when new information or additional materials are available. Attendees who wish to make a verbal comment at the meeting must submit a request form, found at the bottom of the registration page, by September 14, 2021. The meeting's agenda, additional materials, and any other updates will be posted to FDA's website as they become available. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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