FDA Announces Inaugural Products to Receive Commissioner’s National Priority Vouchers

The U.S. Food and Drug Administration (FDA) announced in June 2025 the establishment of a new Commissioner’s National Priority Voucher (CNPV) program and began accepting applications, promising those selected an accelerated review process for drug or biologic applications of one to two months and enhanced communication for sponsors, featuring a more teams-based review approach and a “tumor style” group meeting that brings together FDA staff from review offices….
By: Holland & Knight LLP