Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines
PhRMA
SEPTEMBER 12, 2022
As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline.
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