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FDA Update on Draft Guidance for Digital Health Technologies in Clinical Trials

Three FDA representatives provide guidance on how clinical trial sponsors, investigators and sites can use DHTs to collect data remotely from clinical trial participants.

November 28, 2022
FDA Update on Draft Guidance for Digital Health Technologies in Clinical Trials
Summary:

In this podcast, you will hear three FDA representatives provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial participants. 

They spoke specifically on guidance updates; the requirements to test all of these digital health technologies; efforts the agency is putting in place to harmonize the requirements across the board; guidance to the industry for harmonization; and FDA update on approval of additional clinical measures. This conversation was moderated by Dr Lauren Oliva, Biogen, at the 2022 Mobile Tech in Clinical Trials conference. 


To learn more about the Mobile Tech in Clinical Trials conference, please visit mobileinclinicaltrials.com

Speakers

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