PDUFA VII: More Changes Coming in the Latest Reauthorization
Camargo
JANUARY 12, 2022
As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. However, the anticipated impact of PDUFA VII will extend well beyond those industry segments.
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