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FDA’s speedy voucher program reportedly shelved, but HHS says pilot is ongoing

A Reuters report dated November 12 says the FDA has effectively shelved the Commissioner’s National Priority Voucher (CNPV) pilot, launched in 2025 under former Commissioner Marty Makary to accelerate selected drug reviews to as little as one or two months. According to Reuters’ six sources and internal documents, no new vouchers have been awarded since Makary left in May, the political-appointee executive council overseeing the program has gone dormant, and companies’ new applications reportedly are not advancing. The program’s status is disputed: an HHS spokesperson says the pilot is ongoing while the FDA reviews feedback from a June public hearing and considers how to refine it. There has been no formal announcement terminating the program. The report concerns this specific commissioner-led pilot—not every FDA expedited-review pathway. Existing voucher recipients may still be undergoing reviews. Sources: EXCLUSIVE: US FDA shelves commissioner's voucher program for sp...

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