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Investing.com -- The U.S. Food and Drug Administration has introduced a new Commissioner’s National Priority Voucher (CNPV) program aimed at accelerating the drug approval process for treatments that address key American health priorities.
The program will dramatically reduce review times from the standard 10-12 months to just 1-2 months after final drug application submission, according to the FDA’s announcement on Monday.
Unlike the traditional review process where applications are sent to multiple FDA offices, the CNPV program will utilize a team-based approach. A multidisciplinary team of physicians and scientists will pre-review submitted information and meet for a one-day "tumor board style" discussion to evaluate clinical data.
"Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public," said FDA Commissioner Marty Makary M.D., M.P.H.
Makary, who has experience as a surgical oncologist, explained that the program adapts the multidisciplinary decision-making model used in medical settings to the drug approval process. "This voucher harnesses that model to deliver timely decisions for drug developers," he added.
During the program’s first year, the FDA plans to distribute a limited number of vouchers to companies working on products that align with U.S. national health priorities. These priorities include addressing health crises, delivering innovative cures, meeting unmet public health needs, and increasing domestic drug manufacturing as a national security measure.
Companies that receive vouchers may also qualify for accelerated approval if their products meet legal requirements. The program will feature enhanced communication between the FDA and drug sponsors throughout the review process.
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