FDA Finalizes Guidance on Evaluating Drug Effects on Driving Ability

Clinical Trials Advisor
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The FDA published guidance assisting sponsors in evaluating the effects of psychoactive drugs on the ability to operate a motor vehicle. The agency recommends a tiered approach to evaluating drug effects, consisting of pharmacology/toxicology, epidemiology and clinical behavioral assessments. Data obtained early in development can be used to guide the collection of subsequent data related to driving impairment, for a better allocation of sponsor resources.

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