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Bethesda North Marriott Hotel and Conference Center

Oct 25, 2017 7:00 AM - Oct 26, 2017 3:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Combination Products Conference

Innovation and New Frontiers

Back to Agenda

Session 1: FDA News Feed: 2017

Session Chair(s)

Rachel Turow, JD, MPH

Managing Counsel, FDA Regulatory

Walmart, Inc., United States

FDA regulation of combination products has seen huge advances in recent years. Both PDUFA VI and 21st Century Cures have included programmatic changes for combination products, and FDA has been busy issuing guidance and regulations as well as implementing organizational changes to aid in the review of combination products. The Office of Combination Products will give an update on all of these aspects and forecast some future issues we might see addressed under the new FDA Commissioner.

Learning Objective :
Describe recent regulatory changes for combination products
Identify the top policy priorities for FDA’s Office of Combination Products
Discuss recently issued guidances and regulations as well as internal FDA changes affecting combination products

Speaker(s)

FDA News Feed: 2017

John Weiner, JD

FDA, United States

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

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