The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency. The federal outfit’s ...

The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of frequently asked questions.

The FDA has handed out the first nine national priority vouchers, positioning companies including Merck KGaA, Regeneron and Sanofi to complete the approval process in one to two months. FDA ...

On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests.

The FDA is implementing a new pilot program that could incentivize development of certain new drugs by dramatically shortening their regulatory reviews. But to qualify, a drug must address specified ...

A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient will be manufactured in the U.S. These are among the first nine therapies ...

The U.S. FDA has revealed plans to launch a national priority voucher program aimed at reducing the drug review time period for selected manufacturers. The time to review a drug under the program will ...

The FDA awarded two national priority review vouchers through its Commissioner’s National Priority Voucher pilot program on Dec. 19, bringing the total granted to 18. The latest vouchers were issued ...

The FDA named the first nine products to undergo a new expedited review process that takes 1 to 2 months, the agency announced on Thursday. The nine companies selected to participate in the FDA ...

Against the stark backdrop of the FDA job cuts, stakeholders in the rare disease space find themselves facing heightened uncertainty. In late March 2025, the Trump administration moved forward with ...