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report

PhRMA’s Comments to U.S. Food and Drug Administration’s Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices

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PhRMA submitted comments to the U.S. Food and Drug Administration (FDA) in response to the draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. PhRMA supports the FDA’s efforts to provide details regarding its expectations for the design and conduct of decentralized clinical trials (DCTs). With thoughtful implementation, DCTs can have positive, lasting implications on how medicines are developed.
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