FDA Approves First Cancer Drug Through Pilot Review Programs

By David Roza / July 18, 2018 at 3:56 PM
FDA approved new uses of a cancer drug using two new pilot review programs that aim to streamline the review of cancer drugs and improve the standards for evaluating safety and efficacy, the agency announced Wednesday (July 18). The approval, the first under the pilots, comes less than a month after sponsors submitted an application on June 28, and several months ahead of the goal date, said FDA Commissioner Scott Gottlieb. The quick turnaround shows off the effectiveness of the...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.