News Brief: U.S. FDA Launches Commissioner’s National Priority Voucher (CNPV) Program

The FDA has introduced a new initiative called the Commissioner’s National Priority Voucher (CNPV) program. This program is designed to accelerate the review process for drug applications that align with key U.S. national health priorities.

The CNPV program’s goal is to reduce the FDA’s standard drug review timeline from 10–12 months to just 1–2 months. A limited number of vouchers will be granted in the program’s first year.

Eligibility

Vouchers will be awarded to companies that:

• Address a U.S. health crisis
• Deliver innovative cures
• Meet unmet public health needs
• Support domestic drug manufacturing

Review Process

The CNVP process will convene experts from FDA offices for a team-based review.

“As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion,” said FDA Commissioner Marty Makary, MD, MPH. “This voucher harnesses that model to deliver timely decisions for drug developers.”

For more information, go to FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests