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Keynote Address: Combination Product Regulation – A Combination Perspective
Session Chair(s)
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
Discuss FDA’s assignment and regulation of combination products from a unique perspective – that of someone who helped develop key combination product regulations and policies while at FDA, and who now works as a consultant on behalf of sponsors seeking to develop combination products.
Speaker(s)
Kate Cook, JD
Greenleaf Health, United States
Principal, Regulatory Policy