Snapshot

The Commissioner’s National Priority Voucher (CNPV) Program pathway has been developed by the of United States.

This pathway can be used where drugs in any area of medicine that address a health crisis in the U.S., bring potential innovative therapies to the American people, address unmet public health needs, and/or significantly increase the national security of the U.S. The program does not currently apply to devices or combination drug-device applications..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is The U.S. Food and Drug Administration announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 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. 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. The FDA plans in the first year of the program to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this 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 new review program will also include enhanced communication with the sponsor throughout the process. The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of: 1. Addressing a health crisis in the U.S. 2. Delivering more innovative cures for the American people. 3. Addressing unmet public health needs. 4. Increasing domestic drug manufacturing as a national security issue. To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application. Sponsors must also be available for ongoing communication with prompt responses to FDA inquiries during the CNPV review. The FDA reserves the right to extend the review window if the data or application components submitted are insufficient or incomplete, if the results of pivotal trial(s) are ambiguous, or if the review is particularly complex. .