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FDA Issues Draft Guidance on Use of Decentralized Clinical Trials The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. “Decentralized Clinical Trials for …
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FDA Highlights Exemptions for Real World Data-identified AEs On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) …
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