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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.