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

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Recorded March 11, 2021 | On-Demand Webinar

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.

his session was recorded as part of FDLI’s virtual Introduction to Biologics and Biosimilars Law and Regulation course in March 2021.

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