Join FDLI as we launch our newest book, How FDA Really Works: Insights from the Experts. Hear directly from many of the authors and the co-editors, who will highlight their best tips and tactics for how to get the most out of your relationship with FDA. This is a first-of-its-kind book, providing information and expertise to help navigate the complexities of myriad FDA processes across regulated industries. At this event, the authors will provide their insights and observations for effectively communicating with the agency on items ranging from product applications to regulatory compliance and policy matters, with ample opportunity to ask questions. 

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How FDA Really Works: Insights from the Experts

Edited by Wayne L. Pines and Jessica L. Zeller, with 24 chapters from contributing authors

For those seeking to navigate a product application, address a regulatory issue, or establish or change a policy, success in navigating the Food and Drug Administration maze can be formidable. In a first-of-its-kind book, authors who are top experts in their fields share their essential insights from their experiences interacting with FDA—or as FDA employees themselves—to help illuminate the complexities of the regulatory process and provide observations for effectively communicating with the agency.


James N. Czaban, Chairman, FDA Practice Group, Loeb & Loeb LLP
Wayne L. Pines, APCO Worldwide
Anand Shah, Leonard Davis Institute of Health Economics, University of Pennsylvania
Nicole Taylor Smith
Jessica L. Zeller, Edwards Lifesciences


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