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FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials | Epstein Becker & Green

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled. ....

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FDA Guidance: Clinical Protocols, Telemedicine Platform Review

Food and Drug Administration’s guidance investigators can consider telehealth visits so long as no in-person interaction is needed, FDA expects that protocol specify which visits conducted via telehealth and which require the participant to either be seen in person ....

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FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices | McDermott Will & Emery

Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or. ....

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