FDA opens registration for virtual public meeting on reauthorizing the Prescription Drug User Fee Act (PDUFA)

FDA opens registration for virtual public meeting on reauthorizing the Prescription Drug User Fee Act (PDUFA)

On July 23, 2020, 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 the 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 the program’s reauthorization as FDA considers which, if any, features to propose, update, or discontinue in the next PDUFA. The PDUFA VII meeting agenda will include presentations by FDA staff and panels representing multiple stakeholder groups, as well as time allotted for public comment and discussion. Public comments will also be accepted through August 23, 2020 by submission to docket No. FDA-2010-N-0128, which will be published prior to the public meeting. To attend this meeting, please register by June 23, 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 website as they become available.