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2024 Combo Products Summit Agenda

session

Advancing Combination Product Development through FDA User Fee Programs, PDUFA, MDUFA, and Beyond

October 10, 2024 @ 1:20 pm

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2:00 pm

Moderator

Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie

Speakers

James Bertram, Director of the Office of Combination Products (OCP), FDA 
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA
Jill Lee, Senior Director, Regulatory Policy, Novo Nordisk
Annette Marthaler, Senior Regulatory Counsel, Office Of Combination Products (OCP), FDA
Chelsea O’Connell, Director, Global Regulatory and R&D Policy, Amgen
Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA 

The Prescription Drug User Amendments (PDUFA), Medical Device User Amendments (MDUFA), and other important pieces of FDA legislation such as the 21st Century Cures Act, provide FDA with vital resources and policy advancements to carry out its public health mission and ensure patients have timely and continued access to safe, effective, and high-quality medical products. Since FDA’s Office of Combination Products was first established through the Medical Device User Fee and Modernization Act of 2002, critical pieces of legislation have helped streamline combination product development through capacity building, guidance development, and process improvements. This session will highlight these advancements in combination product policies and the continued collaborative efforts across FDA’s product centers and stakeholder communities.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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