31
Jul
PDUFA Fees Announced for FY 2025 - Lachman Blog

PDUFA Fees Announced for FY 2025

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 […]

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23
Aug

PDUFA VII – Getting Ready for the Reauthorization

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 […]

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13
Aug

2022 PDUFA Fees Announced

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 […]

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