An Introduction to Violations, Enforcement, and International Issues in Biologics and Biosimilars

Learn FDA’s enforcement tools and procedures and the factors FDA weighs when making enforcement decisions. Identify prohibited acts of adulteration and misbranding. Understand international harmonization and import and export regulations.

Brian J. Malkin, Partner, McDermott Will & Emery

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 March 2022. 

 

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