FAQs: Commissioner’s National Priority Voucher Pilot Program
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 pilot 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 the 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 a large unmet medical need.
- Increasing affordability.
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 pilot 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 pilot 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 process must be commenced within two years following receipt from the FDA.
Q8: What type of products are candidates for the CNPV designation?
A8: The pilot program can be applied to drugs or biologics.
Q9: How can a company apply for a CNPV?
A9: FDA is now accepting submissions. Companies can submit a statement of interest at www.FDA.gov/CNPV.
Q10. Can a company submit multiple submissions for different products or therapies?
A10. A company is limited to one submission.
Q11. Who will evaluate the submissions?
A11. Submissions will be evaluated by a senior, multi-disciplinary review committee within FDA’s Office of the Chief Medical and Scientific Officer
Q12. How will a company know if they have received a voucher or not received a voucher?
A12. Companies will only be notified via email if additional information is needed to evaluate their submission, or they have received a voucher.
Q13: Who can I contact for additional information about the CNPV pilot program?
A13: Please send inquiries/questions about the CNPV pilot program to: CommissionerVoucher@fda.hhs.gov.
Q14: Will a product selected under one or more criteria be expected to meet all the criteria?
A14: No; the criteria are used at the time of product selection and a given product is not expected to meet all criteria.
Q15: What are the pre-submission requirements and recommendations for new applicants to the CNPV Program?
A: Based on early experience in the pilot, FDA is enhancing pre-submission requirements for any new CNPV voucher recipients as noted below. In general, we would request that sponsors submit any available data to FDA as soon as possible, prior to the submission of the complete application.
At least 60 days before the complete application is submitted, or at least 120 days before if foreign inspections will be needed:
- Required: Submit CMC data, draft labeling
- Required: Specify manufacturing facilities and BIMO BA/BE study sites (clinical/analytical/in vitro)
- Required: Submit relevant information regarding devices for combination products (e.g., manufacturing, human factors, risk assessments)
- Recommended: List no more than 2-3 manufacturing facilities, provide a justification for additional sites
- Recommended: Submit all available data relating to the application (e.g., raw data, toxicology, non-clinical data, clinical/safety data, application components that are complete)
- Recommended: As applicable, submit the items described in the FDA guidance Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry | FDA to facilitate clinical investigator, sponsor, and contract research organization inspection planning. This information is requested for all major (i.e., pivotal) trials used to support safety and efficacy in the application.