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

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

James R. Johnson, Partner, Sidley Austin US 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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