Health and Human Services Department Docket FDA-2023-N-0043 Notice

2023-02479: Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review; Public Workshop

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Summary

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review." Convened by the Duke-Robert J. Margolis, MD Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of the public workshop is to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcome measures using DHTs. Additionally, this public workshop meets a Prescription Drug User Fee Amendments (PDUFA VII) commitment to convene the first of a series of public workshops by the end of the second quarter (Q2), fiscal year (FY) 2023.

The agency’s own summary, as published.

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