Evaluating Drug Effects on the Ability to Operate a Motor Vehicle

Issue Date: November 8, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final

Evaluating Drug Effects on the Ability to Operate a Motor Vehicle

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 FDA-regulated drugs for which such evaluation may be needed2 and the types of studies that such an evaluation entails during clinical trials.

Download the Guidance Document