Introduction to FDA Review and Approval of Biological Products
Learn the statutory definitions of a biological product as well as recognize the distinctions that drive jurisdiction and regulatory pathways. Understand pathways to market and how to determine which pathway to choose. Understand the applicability of both the PHS Act and the FDCA to biological products.
Jewell Martin, Associate Director for US Regulatory Policy, BioMarin Pharmaceutical Inc.
This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2022.