Fees

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 […]