Short Course: Digital Health Technologies for Combination Products and Beyond: Development and Regulation

Wade Ackerman and Christina Kuhn taught the short course “Digital Health Technologies for Combination Products and Beyond: Development and Regulation” at DIA’s Combination Products 2016 conference. When it comes to the regulatory path to market for digital health technologies that touch upon drug products, much attention has been paid to FDA’s device center, but there has been less focus on the role of FDA’s drug center. This course looked at FDA’s evolving regulatory approach to mobile medical apps, clinical decision support software, wearables, and other digital health products that implicate pharmaceuticals or traditional devices.

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