The FDA has selected the first nine products for its Commissioner’s National Priority Review Voucher pilot, a program designed to compress review timelines for candidates that address national priorities. Commissioner Marty Makary announced the cohort and the pilot aims to give qualifying submissions regulatory decisions in roughly two months, a significant acceleration from standard review. The agency published criteria for what qualifies as a national priority, raising debate inside industry and among policy watchers about allocation, transparency and the program’s impact on FDA workload. Companies named to the pilot now face accelerated timelines and heightened scrutiny as reviewers test the pilot’s operational limits.
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