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

A session from FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More
Recorded March 5–6, 2024

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.

David L. Chesney, Principal and GM, DL Chesney Consulting, LLC

This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024. 

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