FDA发布《提交临床试验数据以评估驾驶能力》最终二级指南（2026年10月，Docket FDA-2017-D-6821）
Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle October 2026
美国FDA药品评价与研究中心发布最终二级指南，规定向药品或生物制品上市申请提交驾驶研究数据的技术规范，用于评估药物对驾驶机动车能力的影响。该指南以2017年11月行业指南《评估药物对驾驶能力的影响》为基础，驾驶研究主要评估精神活性药物，也可评估某些非精神活性药物。公众可随时按21 CFR 10.115(g)(5)提交意见，书面意见须标注Docket编号FDA-2017-D-6821。
GUIDANCE DOCUMENT
Final Level 2 Guidance
- Docket Number:
- FDA-2017-D-6821
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This document provides technical specifications for submitting data from a clinical trial to evaluate the ability to operate a motor vehicle (herein referred to as a driving study) to support a marketing application for drug or biological product. As presented in FDA’s guidance for industry Evaluating Drug Effects on the Ability to Operate a Motor Vehicle (November 2017), driving studies are primarily conducted to evaluate the effects of psychoactive drugs on the ability to operate a motor vehicle, though driving studies can also be conducted to evaluate effects of certain non-psychoactive drugs.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6821.
来源：FDA 官方药品与生物制品信息 · fda.gov