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Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?
Session Chair(s)
Nancy Myers, JD
CEO and Founder
Catalyst Healthcare Consulting, United States
FDA’s approach to digital health is evolving. The agency has issued a series of guidances and other policies in recent years on digital health technologies<
Learning Objective : Describe FDA’s current thinking on digital health; Assess the potential impact of digital technologies on FDA priorities such as patient voice, real world evidence generation, post-market safety; Assess future opportunities for digital health to impact medical product development.
Speaker(s)
Panelist
Catherine Kopil, PhD
The Michael J. Fox Foundation for Parkinson's Research, United States
Director, Research Partnerships
FDA Perspective
Jacqueline A. Corrigan-Curay, JD, MD
FDA, United States
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
Panelist
Yarmela Pavlovic, JD
Hogan Lovells, United States
Partner, Global Regulatory
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