PDUFA VII: What's new, and what's significant in the next user fee deal
When PDUFA VI expires in September 2022, all eyes will be on the next five-year user fee deal, including what changes FDA has to make that are significant, new or modified from past deals.
Those details and more made their way into the Federal Register this morning, alongside news of a half-day, public meeting on PDUFA VII set for Sept. 28.
Taking a step back, PDUFA was originally enacted in 1992 as a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain drugs and biologics. The FDA agrees, in exchange for those fees, to meet specific review timelines for new drugs and supplements.
Premium subscription required
Unlock this article along with other benefits by subscribing to one of our paid plans.