FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be fierce. It has been a little over a month since the FDA announced the CNPV…
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between 2020 and 2024. The FDA has described this move as a step toward the Agency’s…
