This webinar will provide strategies to meaningfully establish two-way engagement between FDA and industry. These channels include both formal meeting opportunities and communication between regulatory professionals in informal settings—ombudsman programs, advisory committees, patient engagement listening sessions, and more. Panelists will use practical examples to illustrate how to effectively engage with FDA and address issues in different FDA-regulated product areas using these available channels, as well as appealing agency decisions.

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Meghana Chalasani, Team Lead for the Advisory Committee Team, Office of New Drugs, FDA
Erica M. Katherine, Ombudsman, Office of Regulatory Affairs, FDA
Jen Mercier, Office Director for the Office of Regulatory Operations, Office of New Drugs
Jessica L. Zeller, Vice President, Quality, Regulatory & Public Affairs Counsel, Edwards Life Sciences
Moderated by Lowell M. Zeta, Partner, Hogan Lovells US LLP

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