Overview

This webinar will provide strategies to meaningfully establish two-way engagement between FDA and industry. These channels include communication between regulatory professionals in both formal and informal settings—advisory committees, workshops, webinars, and patient engagement listening sessions, as well as the formal meeting opportunities. 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 how to best utilize the Ombudsman offices, and how to appeal agency decisions within the agency, through citizen petitions, and in court.

Speakers

Jessica L. Zeller, Vice President, Quality, Regulatory & Public Affairs Counsel, Edwards Life Sciences
Lowell M. Zeta, Partner, Hogan Lovells US LLP