We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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.
The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design.
The European Medicines Agency adopted the fifth revision of its substantive guideline covering all stages of oncology drug development, expanding upon the previous version’s section on safety data.