Navigating FDA’s Regulatory Framework for Medical Products
Gain critical insights into the FDA’s approach to regulating drugs, biologics, and medical devices from an expert with demonstrable knowledge of federal intricacies.
October 22, 2015
Cabral Center, Northeastern University
Jeremiah J. Kelly is the Attorney for Medical Product Development and Regulation, Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Materiel Command (USAMRMC) located at Fort Detrick, Maryland. Mr. Kelly advises the Commanding General, USAMRMC, on regulatory and acquisition strategy for the development and life-cycle of drugs, biologics, and medical devices to treat the unique medical needs of the U.S. Army. From 2001 to 2008, Mr. Kelly served in the Office of the Commissioner, U.S. Food and Drug Administration (FDA) where he specialized in analyzing legislation for its impact on FDA’s regulatory authority and advised the Commissioner of Food and Drugs on legislative strategy. From 2008 to 2011, Mr. Kelly was in private law practice at Whiteford, Taylor and Preston LLP where he was a litigator in Federal courts and specialized in complex litigation and food and drug law. Mr. Kelly is the author of a number of food and drug law publications and was a member of the Editorial Advisory Board of the Food and Drug Law Journal for a number of years.