WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration announced launch of a new program to issue Commissioner's National Priority Vouchers or CNPVs, which shortens review time significantly, with a view to support national health priorities. The new CNPV program, which will begin in 2025, aims to accelerate the drug review process for companies while maintaining the FDA's rigorous standards for safety, efficacy, and quality.
The agency noted that the new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time to 1-2 months from around 10-12 months, following a sponsor's final drug application submission.
The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.
In the new process, clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day 'tumor board style' meeting.
In the first year of the program, the agency plans to give a limited number of vouchers to companies aligned with U.S. national priorities, such as addressing a health crisis, delivering more innovative cures, addressing unmet public health needs, as well as increasing domestic drug manufacturing as a national security issue.
The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with such health priorities.
In addition to receiving the benefits of the program, the agency may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval.
The FDA noted, 'Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company's discretion and consistent with the program's objectives.'
The FDA noted that the new CNPV program is separate and not mutually exclusive with the existing Priority Review and Priority Review Voucher or PRV programs, which will continue as is.
Meanwhile, it contains some of the elements and themes of the priority review programs and PRV programs with a different timeline for the review, product designated and product undesignated subtypes, and prohibition on the sale of the voucher.
FDA Commissioner Marty Makary said, '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.'
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