Overview of Biological Products Law and FDA’s Regulatory Processes
Review the statutory framework of how key federal and state agencies regulate biological products. Become familiar with key aspects of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHSA) that define biological products.
Patrick C. Gallagher, Partner, Duane Morris LLP
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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