HHS issues guidance on drugs' effects on driving

HHS issued draft guidance outlining a tiered approach to determining whether psychoactive drugs are likely to impair driving.

The guidance suggests ways to identify early stage drug candidates that may increase the risk of motor vehicle accidents. It says all Phase I candidates, including those intended for non-CNS indications, should be evaluated for CNS effects, and emphasizes that tests performed early in development should have high sensitivity for impairment. For later-stage candidates, it says studies should be designed to clarify the clinical relevance of earlier findings. ...