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.
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP
Alexandre Gapihan, Associate, Morgan, Lewis & Bockius LLP
This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in March 2021.