Next user fee deal reveals where industry won at the negotiating table with FDA
Every five years, the way the FDA and the biopharma industry interact changes, sometimes more than a little bit. While the tried and true processes of drugmaker-FDA interactions remain intact, industry and the FDA spend months at the negotiating table hashing out new ways to alter their interactions and allow for a more consistent, predictable process.
In the case of PDUFA VII, which takes effect in Sept. 2022 and runs through 2027, the 71-page commitment letter between the FDA and industry released Monday spells out exactly what to expect if you’re a sponsor of a new drug application, weaving through this sometimes labyrinthine process.
The letter also offers a window into the FDA’s long-term priorities, particularly on safety-related issues, such as modernizing REMS assessments, using user fees to expand the FDA’s Sentinel initiative for tracking the safety of marketed drugs, and reviewing proprietary names to reduce medication errors.
Premium subscription required
Unlock this article along with other benefits by subscribing to one of our paid plans.