Issue Date: October 20, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Technical Specifications
Status: Final
Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle
This final guidance gives technical specifications for submitting clinical trial data from driving studies that support marketing applications for drugs or biological products. These studies mainly assess psychoactive drugs, though some non-psychoactive drugs may also be studied. This guidance accompanies, and does not replace, FDA’s November 2017 guidance Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.
Download the Guidance Document
