STAT+: Will Makary’s FDA voucher program survive?

Article excerpt

RevMed's experimental pancreatic cancer drug daraxonrasib is accessible through an expanded access program despite lacking FDA approval, but patients face significant hurdles in obtaining it. Meanwhile, the FDA's voucher program championed by former chief Marty Makary faces potential restructuring. The program, designed to accelerate drug development, may undergo substantial changes as the agency reassesses its priorities and implementation.