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Replies to post #2601 on Iovance Biotherapeutics Inc (IOVA)
09/06/25 3:13 PM
Excited for the new National Priority Voucher pilot program! pic.twitter.com/YsIciT0f5P
— Dr. Marty Makary (@DrMakaryFDA) August 21, 2025
FDA Commissioner @DrMakaryFDA talks about promising treatments in the pipeline and the innovations and breakthroughs he’d like to see in the future. pic.twitter.com/KdJKF8QB0w
— U.S. FDA (@US_FDA) July 11, 2025
09/16/25 10:15 AM
“This approval demonstrates FDA flexibility in evaluating applications of therapeutics to treat rare diseases,” Vinay Prasad, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA press release. “When we see the trifecta of plausible mechanism of action, robust pharmacology/biologic science and supportive clinical study data, we promptly act even if that data is derived from a small sample size study.”
During a session at the Sept. 4 Maryland Tech Council BioInnovation Conference, Makary said “in the coming weeks, here, we’ll announce the initial set of products.”
Ideally, a CNPV could allow a one- to two-month review of an application. The review team would pre-review the data submitted in advance and convene a one-day multi-disciplinary meeting.
Eligible products must meet a national priority, such as address a US public health crisis, deliver more innovative cures to the American people, address a large public health need, increase product affordability, or help onshore drug development and manufacturing.
Unlike the agency’s other priority review voucher programs, CNPVs are not transferable and must be redeemed within two years of receipt.
The FDA now is accepting statements of interest from companies willing to participate. Center for Drug Evaluation and Research Director George Tidmarsh said during a Sept. 3 Rare Disease Hub workshop that the agency has received “hundreds” of applications.
The FDA committed to issuing five vouchers during the program’s first year.
“This program is not designed to play favorites, but to help to close significant gaps in our healthcare system and to accelerate the development of therapies to address emerging needs,” Tidmarsh said.
The FDA announced the program in June as another potential pathway for an expedited approval.
Some companies publicized their interest in the program before key details were released, apparently to generate positive headlines.
Tidmarsh, Prasad Helping Pick CNPV Candidates
CNPV submissions will be evaluated by a “senior multi-disciplinary review committee led by the FDA’s Office of Chief Medical and Scientific Officer,” according to the FDA website.
Tidmarsh said that he and Center for Biologics Evaluation and Research Director Vinay Prasad, who also has been renamed FDA CMSO, are “closely involved” in selecting candidates and “assessing and shepherding these programs through the review process.”
Makary also said during an Aug. 18 FDA Direct podcast that the drug review divisions have been asked to submit applications that could be program candidates.
“I think they’re struggling like, ‘hey, we got three products here that could work for this,’” he said. “So we told them they could submit two in this initial round if they feel like there’s a tie. But otherwise, we’re asking each division to submit one.”
Sponsors may only submit one CNPV application, according to the FDA website.
Prasad was FDA chief medical and scientific officer, as well as CBER director, prior to his July 29 departure from the agency. When he returned as CBER director on Aug. 9, he did not immediately regain the CMSO title.
