💊FDA Reopens Comment Period on Prescription Drug User Fee Act VII
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability entitled "Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments" that appeared in the Federal Register of May 9, 2025. In the notice of availability, FDA requested comments on the final assessment report. The Agency is taking this action in response to a request to allow interested persons additional time to submit comments.
Learn More💊FDA Meeting on Reauthorization of Prescription Drug User Fee Act
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website.
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