Q1: What’s the difference between the Commissioner’s National Priority Voucher (CNPV) and the existing Priority Review and Priority Review Voucher (PRV) programs?
A1: These are separate programs and not mutually exclusive. The existing priority review programs and PRV programs will continue as is. The CNPV program will begin in 2025 and 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.
Q2: When will the new vouchers be given out?
A2: The FDA will give out these new vouchers in 2025. After a 1-year pilot phase, the agency may increase the number of CNPVs it gives to companies.
Q3: What criteria are used to determine who gets a CNPV?
A3: The Commissioner will establish national priorities such as, but not limited to:
- Addressing a health crisis in the U.S.
- Bringing potential innovative therapies to the American people.
- Addressing unmet public health needs.
- Significantly increasing the national security of the U.S.
Q4: Are CNPVs transferrable to another company?
A4: These vouchers are non-transferrable. However, they will remain valid through changes in company ownership.
Q5: Does the CNPV program affect pre-existing expedited review programs, such as fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation?
A5: No, the CNPV program will not affect other programs but will incorporate some of their elements.
Q6: Can the CNPV be applied to a product at any stage of FDA review?
A6: Yes, the voucher can be applied to a product at any stage in development. If granted during the investigational new drug phase of a drug, the company will receive the CNPV’s enhanced communication benefits. Interim reviews throughout the process will benefit from enhanced communication and prompt responses.
Q7. Do the CNPVs expire?
A7: Yes, the voucher must be used within two years following receipt from the FDA.
Q8: What type of drugs are candidates for the CNPV designation?
A8: The program can be applied to drugs in any area of medicine. The program does not currently apply to devices or combination drug-device applications.
Q9: How can a company apply for a CNPV?
A9: The agency will provide information in the near future on how companies seeking to apply can indicate their alignment with the FDA Commissioner’s criteria to meet national priorities.
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