FDA Announces Plan To Shorten Drug Review Time In Voucher Program
June 17th, 2025 // 5:19 pm @ jmpickett
FDA announced today that it is starting a program where the FDA commissioner can provide vouchers to drug companies to shorten the review time for a New Drug Application to as little as one or two months, cutting up to a year off the regular review period.
The commissioner’s National Priority Voucher or CNPV program gathers drug experts from various FDA offices for team-based reviews, rather than the traditional drug review system where the NDA was sent to several offices across the country.
FDA will give a limited quantity of vouchers in the next year to firms that are aligned with FDA’s priorities. The new voucher program intends to speed up the NDA process, but still maintain the agency’s focus on safe, effective, and quality drugs. The National Priority Review Plan will allow firms to submit most NDAs before they complete clinical trials, which will reduce inefficiencies and delays.
FDA Commissioner Marty Makary also noted this week that he wants FDA to become nimbler int he next five years to accelerate the development of medical innovation. As part of that process, Makary says FDA is looking at new pilots and programs. He noted that he wants a universal influenza vaccine that would be effective for many strains of bird flue and wouldn’t require yearly immunization.
He also noted that he wants to see better treatments for type 1 diabetes and better cell and gene therapies, especially for the rarest diseases.
Makary said that FDA should ask itself why it takes a decade for new pharmaceuticals to hit the market. He noted that barriers to getting new drugs to patients is often because of the onerous drug approval process, and that FDA needs to question long-held assumptions about legacy systems it uses to put products on the market. “We need to be willing to learn from data that isn’t only from randomized clinical trials. We can learn from data in the real world, and we can learn from synthetic controls available today in national electronic health records.”
