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.
FDA commissioner Dr. Marty Makary is beginning to make moves toward his promise of speeding up drug approval pathways at the agency. But he’s aiming to do things a bit differently than in the past — ...
The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug ...
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 has issued a supplemental biologics license application to teclistamab, a Johnson & Johnson therapy, to participate in its National Priority Voucher pilot program, according to Dec. 15 news ...
Dec 17 (Reuters) - The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with multibillion-dollar potential, according to internal documents seen by ...
The Commissioner's National Priority Voucher program significantly shortens the FDA review time for a sponsor's final drug application submission from approximately 10 to 12 months to 1 to 2 months.
The program significantly shortens the FDA review time for a sponsor's final drug application submission from approximately 10 to 12 months to 1 to 2 months. HealthDay News — On Tuesday, the Food and ...
Merck cholesterol pill enlicitide and cancer therapy sac-TMT tapped for new priority program FDA expects Merck to submit applications in April and autumn of 2026, documents show Both drugs if approved ...
Merck's cholesterol pill enlicitide ​decanoate and its cancer therapy sacituzumab tirumotecan, or sac-TMT, have been tapped ...