FDA posts technical specifications for driving-study data submissions
FDA’s October 2026 final guidance describes how to submit clinical-trial driving-study data supporting drug and biological-product marketing applications.
What the record says
FDA has posted final technical guidance on submitting clinical-trial data used to evaluate the ability to operate a motor vehicle. The guidance page, marked current as of October 20, 2026, says the specifications concern driving studies supporting marketing applications for drugs or biological products. FDA explains that such studies primarily assess the effects of psychoactive drugs on driving, while some studies can also assess non-psychoactive drugs. The page links the document to FDA’s separate November 2017 guidance on evaluating drug effects on driving. The October document is identified as final Level 2 guidance issued by the Center for Drug Evaluation and Research.
Source details and supporting locations.
Practical next step
Sponsors preparing driving-study submissions should consult the complete technical document and applicable FDA guidance.
Limits and what is not established
This is a data-submission notice, not a finding that a particular drug is safe for driving, a new driving ban or individual medical advice.
Sources checked October 22, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information