FDA Draft Guidance references Dr. Gary Kay’s Drugged Driving Report

FDA Draft Guidance references Dr. Gary Kay’s Drugged Driving Report

The purpose of this guidance is to assist pharmaceutical sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Specifically, click this guidance addresses the FDA’s current thinking regarding the FDA-regulated drugs for which such evaluation may be needed, and the types of studies that such an evaluation entails. This draft guidance is intended to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community, and …READ MORE