July 24, 2023
The Alliance submitted comments to the FDA on its "Decentralized Clinical Trials for Drugs, Biological Products and Devices: Draft Guidance for Industry, Investigators and Other Stakeholders."  Overall supporting the guidance and its intent to expand access to diverse locations/populations, the Alliance raised several areas of concern surrounding whether the policy would have the impact that the Agency is striving to achieve. Our comments offer a series of recommendations, as well as highlight specific provisions that would benefit from additional clarity. 

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