Is my product a combination product? Which FDA Center will review my product? How will it be regulated? Sometimes the answers are not obvious. This webinar will begin with addressing these questions. Speakers will then delve into such topics as practices for preparing a Request for Designation (RFD) or Pre-RFD, pre- and post-market requirements for combination products, and other practical and legal considerations. The webinar will also include industry case studies on company hurdles and lessons learned when submitting a product.


John (Barr) Weiner, Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products
Scott Danzis, Partner, Covington & Burling LLP
Kirsten Paulson, Senior Director, Global Reg- CMC Medical Devices, Pfizer, Inc.



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Webinar & Recording

  • +$100 for non-members


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