FDA Evaluating Drug Effects on the Ability to Operate a Motor Vehicle
标准简介
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于United States。标准截图
![Evaluating Drug Effects on the Ability to Operate a Motor Vehicle[附网盘链接]](/img/20210914103744fayhx.jpg)
标准文档说明
标准文档类型为Evaluating Drug Effects on the Ability to Operate a Motor Vehicle[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle 1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION 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 2
may be needed and the types of studies that such an evaluation entails during clinical trials. This guidance does not address the specific methods or instruments used to collect data on driving ability; rather, this guidance outlines the general principles and goals of such studies. Experience suggests that a number of methods may be suitable for providing the necessary data. For specific drug development programs, sponsors should discuss with the appropriate review division the study methods to be used. This guidance also does not address the effects on driving ability from underlying disease, normal aging, or other factors unrelated to regulated drugs (e.g., distracted driving, aggressive driving). Although psychoactive drugs are the focus of this guidance, nonpsychoactive drugs may affect driving ability through effects on function, including intended effects and secondary effects (e.g., impaired consciousness from a hypoglycemic reaction to a glucose-lowering drug, impaired vision from a mydriatic drug). Therefore, the need to consider possible effects on driving ability is not limited to psychoactive drugs, and the approach to evaluating risk for nonpsychoactive drugs, which may differ substantially from the approaches described in this guidance, should be guided by drug-specific effects. 1
This guidance has been prepared by the Division of Neurology Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products unless otherwise specified.
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