LAW 199 v03 : Law and Regulation of Drugs, Biologics and Devices

Last edit: Wed, 15 Jan 2020 20:11:36 GMT

Fall 2020
JD Adjunct
UserID Name Email
sdd42 Danzis, Scott
rfk5 Kingham, Richard
LAW 199 v03: Law and Regulation of Drugs, Biologics and Devices
Law and Regulation of Drugs, Biologics and Devices
T 5:45-8:50p
32 (LAWJ: 22/LAWG: 10)
In-Class Exam


Prior or concurrent enrollment in Administrative Law.


This is a required course for the Food and Drug Law Certificate.

Would you like to offer the Pass/Fail grading option?

Does this course qualify as a "simulation course"?

Is this course available to distance students?

Is this a mandatory Pass-Fail course?


Personal Information


Scott D. Danzis is a partner in the law firm of Covington & Burling LLP where he is a member of the firm’s Food & Drug and Health Care practice groups. Professor Danzis regularly advises clients in the medical device and pharmaceutical industries on a wide array of issues, including the design and conduct of clinical trials, obtaining FDA clearance or approval, advertising and promotion, good manufacturing practice, adverse event reporting, and many other topics. Professor Danzis has authored numerous articles and book chapters regarding FDA regulation of medical products and health care law. He recently edited a book, In Vitro Diagnostics: The Complete Regulatory Guide, published by the Food and Drug Law Institute in 2010. From 2006 to 2008, Professor Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. Professor Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit.  He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif.  He holds a Masters Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.

Key: 242