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Continuing Growth in Combination Products: More Products, More Questions - Perspectives from FDA and Industry
Session Chair(s)
Jayne Ware, MPH, MSc
Senior Director, Global Regulatory Policy
Merck Sharp & Dohme LLC , United States
Forecasts predict continued growth in the global combination product market. New products and changes to marketed combination products raise regulatory issues that challenge both FDA and sponsors. In this session, we will discuss FDA and industry perspectives.
Learning Objective : Describe FDA policies and activities regarding combination products; Recognize the types of combination products; Articulate industry challenges in addressing regulatory requirements and policies and in the product review process; Discuss the steps being taken by industry and FDA to address challenges.
Speaker(s)
Combination Products: Industry Perspective on Current Policy Issues
Daniel Gottlieb, JD
Epstein Becker & Green, P.C., United States
Counsel
Combination Products: Regulatory Perspective
Patricia Love, MD, MBA
FDA, United States
Deputy Director, Office of Combination Products, OCPP, OC
Combination Products: Design Control Requirements for Products Post-Launch
Karen Grinker, MBA
Genentech, A Member of the Roche Group, United States
Senior Technical Manager
Panelist
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
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