FDA Unveils Draft Guides On Adaptive Trials, Master Protocols

FDA on Friday (Sept. 28) issued two draft guidances that agency chief Scott Gottlieb says will help lower the cost of drug development, making it easier for sponsors to bring second and third drugs in a class to market. One guidance lays out ways to design and conduct adaptive clinical trials and the other addresses how to develop master protocols, which allow sponsors to evaluate more than one drug at a time. The guidances expand on the agency's efforts to...