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Renaissance Washington DC Dupont Circle Hotel

Oct 25, 2016 7:15 AM - Oct 26, 2016 3:30 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Combination Products 2016

Current, Evolving, and Future Pathways

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Session 4: Combination Products on Capitol Hill

Session Chair(s)

David E. Paul, JD

Consultant, US Regulatory Affairs, Policy and Strategy

Eli Lilly and Company, United States

The past year has been a time of almost unprecedented congressional attention to improving the combination product development and review processes. Provisions addressing these matters have been included in both House and Senate bills (“21st Century Cures Act,” and “The Combination Products Regulatory Fairness Act,” respectively). In addition to these bills, there has been some discussion of interest in legislation for a potential “third-pathway;” and in 2017 Congress will consider PDUFA VI, the Technical Letter of which also addresses combination product development and review processes. This session’s panel will overview these 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.

Speaker(s)

Wade Ackerman, JD

Speaker

Wade Ackerman, JD

Covington & Burling LLP, United States

Partner

Speaker

Grace Stuntz

Senate HELP Committee, Republican Staff, United States

FDA Policy Advisor

Carla Cartwright, JD, LLM

Speaker

Carla Cartwright, JD, LLM

Johnson & Johnson, United States

Director, Federal Affairs

Diane Johnson, MS

Speaker

Diane Johnson, MS

Johnson & Johnson, United States

Senior Director, North American Regulatory Affairs Policy and Digital Health

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