In the American Health Law Association’s Journal of Health and Life Sciences Law, attorneys examined how to mitigate U.S. Food and Drug Administration regulatory and enforcement risks relevant to academic medical centers, health systems and research institutions.
The article addresses the scope of FDA jurisdiction and the enforcement process; the ways an institution may find itself on FDA’s radar; FDA regulatory requirements associated with various activities conducted at health systems, research institutions and academic medical centers; and best practices for developing a compliance program to mitigate potential regulatory litigation and enforcement risk arising from research, laboratory testing and clinical use of FDA-regulated drugs and devices.
The article was authored by life sciences regulatory & compliance counsel Beth Weinman and Sarah Blankstein, health care partner David Peloquin and health care counsel Stephen Sencer.
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