Introduction to FDA Review and Approval of Biological Products

Review the statutory definitions of a biological product as well as distinctions that drive jurisdiction and regulatory pathway. Discuss pathways to market and how to determine which pathway to choose. Review of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Examine market exclusivities and intellectual property.

Catherine M. Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health, Inc.

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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