💊FDA Meeting on Reauthorization of Prescription Drug User Fee Act
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The notice announces the FDA's public meeting to discuss reauthorizing the Prescription Drug User Fee Act (PDUFA), which impacts business owners in the pharmaceutical industry by influencing fee structures and regulatory processes crucial for drug applications. The legislation affects funding and resources for drug reviews, directly impacting companies' ability to bring products to market.