As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing

The difference between the cost of standard and priority assessments continues to narrow, a signal not only of the growing popularity of expedited pathways, but also that the US Food and Drug Administration eventually may not need a full 12 months to determine the fate of an application.

Embedded in the calculations for the FY 2022 material threat medical countermeasure, rare pediatric disease, and tropical disease priority review voucher redemption fees, published 30 September in...