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FDA to offer faster drug reviews to companies promoting ‘national priorities’
- The FDA announced the Commissioner’s National Priority Voucher pilot program to speed drug reviews aligned with U.S. national interests starting in 2025.
- This program follows the failure of Congress to renew the rare disease priority review voucher by the end of 2024 and aims to incentivize timely drug development.
- CNPV reviews will convene multidisciplinary expert teams in tumor board-style meetings and can shorten review times from 10-12 months to one or two months.
- Dr. Marty Makary highlighted that shortening the review period to one month could create significant financial incentives for companies, potentially increasing their market valuation substantially, while ensuring that scientific assessments remain independent and free from inappropriate influence.
- Although advocates welcome faster access to therapies, some critics worry that accelerated reviews might risk patient safety and comprehensive monitoring of long-term effects.
90 Articles
90 Articles
The Laconia Daily Sun
FDA Offers Speedier Approvals to Drug Companies Aligning With 'National Priorities'
WEDNESDAY, June 18, 2025 (HealthDay News) -- On Tuesday, the U.S. Food and Drug Administration announced a new initiative to offer expedited reviews for new medicines, an initiative that will apply to drugs that administration officials determine promote "the health…
FDA Voucher Program to Reduce Drug Review Times, Commissioner Says
The Food and Drug Administration will complete reviews of certain drugs more quickly, the agency’s commissioner announced on June 17. FDA Commissioner Dr. Martin Makary said the new Commissioner’s National Priority Voucher program will help reduce the time the agency spends reviewing final applications for drugs. “Through this pilot, companies will receive a decision within a month or two, as opposed to the typical 10 to 12 months,” Makary said …
PharmaTher Applauds FDA's New Commissioner’s National Priority Voucher (CNPV) Program, ...
TORONTO, June 18, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a company focused on unlocking the pharmaceutical potential of ketamine, today announced its strong support for the U.S. Food and Drug Administration's…
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