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# Motor Vehicle Drug Effect Guidance
- URL: https://www.fdaweb.com/motor-vehicle-drug-effect-guidance/
- Published: 2017-11-09T12:00:00.000Z
- Updated: 2026-09-14T23:01:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140096

FDA has issued a guidance, *Evaluating Drug Effects on the Ability to Operate a Motor Vehicle*, to assist drug sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM430374.pdf?ref=fdaweb.com) specifically addresses the agency’s current thinking about FDA-regulated drugs for which such evaluation may be needed, and the types of studies that such an evaluation entails during clinical trials.

The guidance does not address the specific methods or instruments used to collect data on driving ability, but instead outlines the general principles and goals of such studies. “Experience suggests that a number of methods may be suitable for providing the necessary data,” it says. “For specific drug development programs, sponsors should discuss with the appropriate review division the study methods to be used.”

Also not addressed in the guidance are the effects on driving ability from underlying disease, normal aging, or other factors unrelated to regulated drugs. The guidance’s contents include Introduction, Background, The Need to Evaluate Driving Impairment, Tiered Approach to Evaluating Drug Effects on Driving Ability, and Labeling.