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The FDA received a wide range of comments and questions Monday at a public meeting to receive comments on a discussion document on patient-focused drug development — an early draft for the agency’s planned series of guidances on the topic. Read More
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 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— as opposed to maintaining its own — and it is urging sponsors of biologics to do the same, according to a new draft guidance.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
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
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
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. Read More
The European Medicines Agency and the European Network for Health Technology Assessment released a joint work plan to help medicine developers improve clinical research and become more efficient in generating the evidence needed for both agencies. Read More
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
A new requirement has been added to the FDA’s Reviewer Certification Program — training in the development, evaluation and use of patient-reported health outcomes, the agency said in its first report on PROs in medical device premarket submissions and post-market studies. Read More
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
China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to remove barriers to expediting reviews. Read More
For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multi-arm, multi-company clinical trials, according to a new draft guidance that the FDA says could help eliminate the need for certain studies. Read More