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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 Bradish 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)
Catherine Kopil, PhD
Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson's Research, United States
Panelist
Jacqueline A. Corrigan-Curay, JD, MD
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States
FDA Perspective
Yarmela Pavlovic, JD
Partner, Global Regulatory, Hogan Lovells, United States
Panelist
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