FDA releases draft PDUFA VIII commitment letter outlining goals and enhancements for 2028-2032
read at raps ↗RegulatoryNeutral
The FDA on Thursday issued a proposed commitment letter for the upcoming PDUFA VIII cycle, which will cover fiscal years 2028 through 2032.
The letter sets out the agency's performance targets for the program, including timelines for review, user-fee collections, and metrics intended to improve predictability for drug sponsors.
It also describes several enhancements, such as expanded use of digital tools, increased transparency of review milestones, and initiatives aimed at strengthening collaboration with industry and patient groups.
source
This writeup was produced by pharmadog from original reporting by raps.
Original headline: “PDUFA VIII: FDA outlines goals, program enhancements in commitment letter”
read at raps ↗
comments(0)
5-min edit window · permanent after that