The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with clinical trials.
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With an aim of supporting both patients, medical device developers and policymakers, the FDA’s Center for Device and Radiological Health (CDRH) has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions and expansion of decentralized trials.
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The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance advising sponsors to include both clinical and preclinical information in the investigator’s brochure when applying for medical device trial authorization.
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This week’s Pipeline features a phase 1 trial approval for narcolepsy, a phase 1 trial start for mild-to-moderate Alzheimer’s disease and an FDA approval for a Crohn’s disease maintenance therapy.
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