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On Remote Control: FDA Issues Draft Guidance to Facilitate Use of Digital Health Technologies for Remote Data Acquisition in Clinical Trials | Goodwin

During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in...
Device Development Tool Qualification Program Digital Health Technologies Remote Data Acquisition Clinical Investigations Federal Food Cosmetic Act

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials | Bass, Berry & Sims PLC

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled...
United States Human Service Department Of Health Advisory Committee On Human Research Protections Risk Considerations When Using Digital Health Technologies Drug Administration

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