PDUFA VII negotiations near finish line with plans to revamp CBER and staff up
Negotiations for the next Prescription Drug User Fee Act (PDUFA VII) are approaching their end as both FDA and biopharma industry reps agreed in their last steering committee meeting in mid-February to resolve any outstanding issues with the generally agreed-upon commitment letter, proposed statutory changes, and statutory justifications via email.
The negotiations decide how the FDA will use industry’s hundreds of millions of dollars in fees from 2023 to 2027, and what, in addition to the timely reviews, the biopharma industry will receive for its payments.
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