Research and Development

EMA Adopts Guideline on Treatments for Autism

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. Read More

EMA Adopts ICH Guideline on Multi-Region Clinical Trials

The European Medicines Agency adopted the International Council for Harmonisation’s E17 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more efficient drug development. Read More

CBER Urges Sponsors to Adopt International Standards

CBER said it will prefer using internationally harmonized standards developed by third-party organizations — as opposed to maintaining its own — and it is urging sponsors of biologics to do the same, according to a new draft guidance. Read More

FDA Finalizes Guidance on Evaluating Drug Effects on Driving Ability

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. Read More

FDA Releases Guidances on Dual 510(k)-CLIA Waiver Submissions

The FDA issued two draft guidances to encourage using the 510(k)-Clinical Laboratory Improvement Amendments (CLIA) waiver dual application pathway for new in vitro diagnostic devices, and to update its policies for demonstrating accuracy to obtain a CLIA designation. Read More

FDA Updates Investigational Device Guidance

The FDA issued final guidance explaining the new framework the agency will use when assigning IDE devices to one of two categories prior to clinical studies — Category A: Experimental and Category B: Nonexperimental/investigational. Read More