What are the FDA FY 2027 PDUFA fee rates?

FDA published FY 2027 PDUFA fees on July 30, 2026, with all three main categories slightly below FY 2026 levels. Application fees are $4,600,753 with clinical data and $2,300,376 without, while the annual program fee is $416,857; FDA also said payments must be electronic and user-fee inquiries now go to a centralized inbox.