Regulating Medical Innovation in the Digital Age

Regulating Medical Innovation in the Digital Age



Over the last decade, the Food and Drug Administration has worked hard to take a more nimble approach to regulation, increase the number of approvals, prioritize truly innovative products, and integrate patient perspective into its evaluations. Now the agency is facing challenges relating to regulating medical products in the digital age - digital health technologies, machine learning algorithms, integration of data and evidence from non-traditional sources, digiceuticals, and adaptive trials based on complex biostatistical methods, and more. Is the agency prepared to regulate this brave new world unfolding at warp speed? What are the promises and potential pitfalls of these new technologies for patients?

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Lisa Suennen Managing Partner, Venture Valkyrie, LLC


William Carson, President and CEO, Otsuka Pharmaceutical Development and Commercialization

Aneesh Chopra, President, CareJourney

Sohini Chowdhury, Deputy CEO, The Michael J. Fox Foundation

Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health

Jeffrey Shuren, Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Published October 24, 2018