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Hyatt Regency Bethesda

Sep 28, 2015 7:30 AM - Sep 29, 2015 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.

Back to Agenda

Session 1: FDA Update on Combination Products

Session Chair(s)

Steven B. Binion

Steven B. Binion

Director, Policy, Technology, and Communication - Corporate Regulatory Affairs

Becton Dickinson, United States

Leadership from the Office of Combination Products will provide an update on recent and pending activities at FDA. The discussion will address premarket and postmarket regulatory issues as well as agency systems and procedures to support a cross-cutting, collaborative approach to regulation of combination products.

Speaker(s)

Thinh X. Nguyen

FDA Update on Combination Products

Thinh X. Nguyen

FDA, United States

Director, Office of Combination Products, OCPP

John Weiner, JD

Speaker

John Weiner, JD

FDA, United States

Associate Director for Policy, Office of Combination Products, OCPP, OC

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