As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing
US FDA’s priority review voucher fee will decrease again in FY 2022 as the cost of a priority assessment continues to trend closer to the cost of a standard assessment.
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Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
Standard NMEs and BLAs decrease along with their review times, as more sponsors use priority pathway.
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.