Gottlieb: Shutdown Among The Greatest Challenges In FDA History

FDA Commissioner Scott Gottlieb said the month-old partial government shutdown “represents one of the most significant operational challenges in FDA’s recent history,” and he warned that more staff will be furloughed as the agency’s drug center runs out of Prescription Drug User Fee Amendment (PDUFA) funding. “We simply won’t have enough PDUFA-related work to support all of our staff,” Gottlieb told stakeholders on Friday (Jan. 18) at the start of a public hearing on the role drug therapies can play...