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

A session from FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies
Recorded October 26–27, 2022

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.

Rebecca Williams, Associate, Ropes & Gray LLP

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.

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