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.
This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in March/April 2020.
- +$100 for nonmembers
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