The FY 2026 user fees have been announced! The Federal Register (FR) Notice related to Prescription Drug User Fees (PDFUA) can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, MDUFA, and ADUFA. The fees increased by 8.6% for applications, which is a larger increase when compared to that from […]
Yesterday’s pre-publication Federal Register Notice (here) announced the Prescription Drug User Fees Act (PDUFA) program fees to be charged to fee-paying new drug applications for FY 2025. As you will note from the chart below, the application fees increased, but the program fee decreased. It is interesting that the magnitude of the application fee increases were […]
Today, in the pre-publication of the Federal Register (here), the Agency announced a notice of public meeting to receive comments and discuss the material negotiations that have taken place between the industry stakeholders and itself. The notice provides an interesting historical look at the evolution of the PDUFA program since its initial 5-year iteration in […]
After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA fees have been announced in a pre-publication of the FR here. So, this ends the announcements for the 2022 UFAs and you can take that to the bank! The new PDUFA […]
Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication. PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below. We await the GDUFA fee announcement, which we should see in a day or […]
