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FDA clinical trial diversity workshop reveals agency's expectations for sponsors | Hogan Lovells

On November 29 and 30, the U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative, hosted a public workshop on ways to increase the.

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An Overview Of FDA Efforts To Encourage DHT Use In Drug Biological Product Development

An Overview Of FDA Efforts To Encourage DHT Use In Drug Biological Product Development
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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(FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled.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FDA Releases Draft Guidance On Decentralized Clinical Trials

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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