The Regulation of Biological Product Marketing: An Introduction

Discuss the legal and regulatory requirements surrounding communications about biologics and biosimilars. Examine the definitions of misbranding, label and labeling, and off-label promotion. Explore the basic rules for advertising and promotion.

Kevin M. Madagan, Partner, Reed Smith LLP


This session was recorded as part of FDLI’s Virtual Introduction to Biologics  and Biosimilars Laws and Regulations Course in October 2021. 



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