Guidance for Industry
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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, 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 This draft guidance is intended to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community, and the public.