Zdrowie i gospodarka · 30/08/2018

FDA Announces Pilot Meeting Program to Advance Complex Clinical Trial Designs

The US Food and Drug Administration (FDA) is launching a pilot meeting program to facilitate the use of innovative clinical trial designs, as part of its efforts to advance the Prescription Drug User Fee Act (PDUFA VI) and the FDA Reauthorization Act of 2017 (FDARA). The program aims to promote collaboration between the FDA and medical product developers to discuss regulatory approaches for complex adaptive, Bayesian, and other novel clinical trial designs.