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Will The CNPV Program See Its First Birthday?
Following some questions we posed about the efficacy and legality of the Commissioner’s National Priority Voucher (“CNPV”) Program (the “CNPV Program” or “the Program”) in our 2026 Top of Mind Publication, it is again time to ponder the Program’s future, now that its purported champion, former U.S. Food & Drug Administration (“FDA” or the “Agency”) Commissioner, Marty Makary, M.D. (“Dr. Makary”) is out of office. When Dr. Makary resigned earlier this month, he left behind an agency in transition, replete with a portfolio of ambitious reform initiatives that now face an uncertain future.
Sheppard, Mullin, Richter & Hampton LLP