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DIA 2016 Combination Products: Current, Evolving, and Future Pathways

Date: Monday, October 24, 2016 7:00 AM - Wednesday, October 26, 2016 4:00 PM

Venue: Renaissance Washington DC

Wade Ackerman and Christina Kuhn are teaching the short course “Digital Health Technologies for Combination Products and Beyond: Development and Regulation” at DIA’s Combination Products 2016 conference on October 24. 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 will look 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.

Mr. Ackerman will also participate in a session entitled: "Combination Products on Capitol Hill" at the conference on October 25. The session’s panel will provide an overview of recent bills from the perspectives of industry, the agency, and congressional staffers; discuss the Hill’s interests in legislation; and explore the possible fates of these bills or their provisions.

DIA is a leading professional community for the health care product development industry, dedicated to providing a neutral and transparent forum for the exchange of ideas and collaborations to advance global scientific and medical innovations.

For additional information, click here.