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BioWorld - Thursday, May 7, 2026
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Home » US FDA pondering next steps for CNPV
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US FDA pondering next steps for CNPV

March 30, 2026
By Mari Serebrov
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Introduced last year as a pilot program, the U.S. FDA Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV last June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway,” one to two months instead of the standard 10 to 12 months, for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency.
BioWorld Analysis and data insight Regulatory Cancer Diabetes Endocrine/metabolic Obesity U.S. FDA

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