FAQs: Commissioner’s National Priority Voucher Pilot Program
Q1. Is FDA still awarding vouchers?
A1. FDA is now primarily focused on implementation of the pilot. However, FDA continues to accept statements of interest for possible acceptance into the pilot program and may award additional vouchers consistent with the eligibility criteria for the program.
Q2. What criteria are considered for voucher selection?
A2. The criteria currently considered for voucher selection are described in the publicly available Staff Manual Guide (SMG) and FDA’s website.
Q3. What documentation is available regarding the CNPV Program?
A3. FDA has published a Staff Manual Guide describing the role of the CNPV Council and the voucher selection process, including the criteria applied to voucher selection and the individuals involved. Additional materials are available on the program landing page, including a Fact Sheet and Town Hall slides. FDA intends to provide additional documentation (e.g., draft guidance) for external stakeholders in the coming months as the program matures and feedback from internal and external stakeholders is incorporated.
Q4. Will the public have an opportunity to provide feedback on the program?
A4. Yes. FDA intends to issue a request for feedback through a Federal Register Notice (FRN) and to open a public docket. FDA also intends to host listening sessions with external stakeholders.
Q5. What is the role of the “tumor-board style” panel in drug approval decisions?
A5. This panel—now referred to as the CNPV Review Council—does not make decisions regarding drug approval. The CNPV Review Council meets with the primary review team to discuss part of an application and makes a non-binding recommendation to the relevant Center Director on approvability with respect to that part of the application. Decisions regarding drug approval remain within the FDA Centers and follow the usual FDA processes.
Q6. Who evaluates CNPV product applications?
A6. Product applications are reviewed by FDA primary review teams with the appropriate subject matter expertise.
Q7. What is the difference between the CNPV and existing Priority Review and Priority Review Voucher (PRV) programs?
A7. These are separate programs. Existing Priority Review and PRV programs will continue unchanged. The CNPV pilot incorporates some elements of these programs but differs with regard to key factors (e.g. review timelines, product designation) and includes a prohibition on the transfer of the voucher to another company. Additional details are available in the SMG and on FDA’s website.
Q8. Are CNPVs transferable to another company?
A8. No. CNPVs are non-transferable; however, they remain valid through changes in company ownership.
Q9. Does the CNPV pilot affect existing expedited programs (e.g., Fast Track designation, Breakthrough Therapy designation, Accelerated Approval, or Priority Review designation)?
A9. No. The CNPV pilot does not affect existing expedited programs, although it incorporates some of their elements.
Q10. Can a CNPV be applied to a product at any stage of FDA review?
A10. Yes. A voucher may be applied at any stage of product development. If granted during the investigational phase, the sponsor may receive enhanced communication benefits, including more frequent interactions and prompt responses throughout development and review.
Q11. Do CNPVs expire?
A11. Yes. FDA expects that the voucher process would generally be initiated within two years of voucher issuance.
Q12. What types of products are eligible for the CNPV designation?
A12. The pilot program applies to drugs, biologics, and certain combination products.
Q13. How can a company apply for a CNPV?
A13. Companies may submit a statement of interest through www.fda.gov/CNPV. In addition, products with applications already under review at FDA may be nominated internally by FDA review divisions. Sponsors with applications currently under review who are interested in CNPV consideration should discuss this interest with the appropriate review division to be considered for internal nomination.
Q14. How will a company know whether it has received a voucher?
A14. FDA may contact companies during the evaluation process if additional information is needed. Companies will be notified by email if they are awarded a voucher.
Q15. How much time do FDA review teams have to conduct reviews under the CNPV pilot?
A15. The Town Hall slides posted on the CNPV landing page provide an overview of the CNPV application review process and associated review timelines. Current targets include a pre-submission period of approximately 60 days, an abbreviated filing period to assess for application completeness, and a target application review period of approximately 1–2 months.
Q16. Who can be contacted for additional information about the CNPV pilot program?
A16. Questions regarding the CNPV pilot program may be sent to CommissionerVoucher@fda.hhs.gov.
Q17. What are the pre-submission requirements and recommendations for new CNPV applicants?
A17. Based on early experience with the pilot, FDA is enhancing pre-submission requirements for new CNPV voucher recipients. Sponsors are encouraged to submit any available data as early as possible, prior to submission of the complete application. FDA also recommends that sponsors schedule a meeting with the appropriate review division to plan and coordinate submission timelines.
Sponsors should submit the following information at least 60 days before submission of the complete application, or at least 120 days before submission if foreign inspections are anticipated:
Required
- Submit CMC data and draft labeling.
- Identify manufacturing facilities and BIMO BA/BE study sites (clinical, analytical, and/or in vitro).
- Submit relevant information for devices included in combination products (e.g., manufacturing information, human factors data, and risk assessments).
Recommended
- Limit the number of manufacturing facilities to no more than 2–3 and provide justification for any additional sites.
- Submit all available data related to the application (e.g., raw data, toxicology data, nonclinical data, clinical and safety data, and any completed application components).
- As applicable, submit the information described in Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions to facilitate inspection planning for clinical investigators, sponsors, and contract research organizations. This information is requested for all major (i.e., pivotal) trials used to support safety and efficacy.
Q18. What tools and technologies are being explored as part of the CNPV pilot?
A18. FDA is exploring the use of internally developed agentic AI-based tools to streamline specific components of the review process (e.g., filing checklist assessments). These tools will always incorporate gold-standard reviewer oversight and validation. As these tools mature, FDA intends to share additional information with external stakeholders. FDA is also introducing the voluntary use of concise review templates that may be customized and completed collaboratively by sponsors and reviewers to support more efficient reviews. Similar assessment aids have been used successfully in other accelerated review programs within FDA. Additional information on this review template is available at: Assessment Aid | FDA.