FDA Update on Digital Health Technologies in Clinical Trials Draft Guidance

Mobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial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. Following the discussion, the FDA representatives hold open Q&A.

Topics include:

• 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 in terms of how we create the harmonization. What do we need to disclose? And in what timeframe?
• FDA update on approval of additional clinical measures

Speakers:

• Lauren Oliva, PharmD, Director, Global Regulatory Policy, Lead, Digital Health Regulatory Policy, Biogen
• Anindita Saha, Assistant Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA
• Leonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA
• Elizabeth Kunkoski, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA