• Represented a specialty-needs food manufacturer in conducting a Class 1 food recall (recalls with the most serious threat to the public) in cooperation with the U.S. Food & Drug Administration (FDA) and Health Canada.
• Advised sophisticated plastic surgery practice on the applicability of FDA's human cell, tissue, and cellular and tissue-based product (HCT/P) regulations to the autologous use of pluripotent stem cells.
• Advised a national association in a medical field on the applicability of FDA's human subject protection regulations to a novel category of research.
• Represented pharmaceutical company in labeling dispute with the Food & Drug Administration.
• Defended county government against CERCLA, RCRA, and environmental tort claims.
• Represented Class 1 freight railroad in property dispute with developer.
• Represented insurance company in a large property damage, business interruption dispute.
• Legislative Analyst, Office of Legislation, Office of the Commissioner, U.S. Food & Drug Administration, specializing in drug issues such as follow-on biologics, generics, drug approval, and compliance matters.
  • Member, FDA's Working Group on Follow-on Protein Products
  • 2003: FDA Group Recognition Award: OL Drugs Team, "Outstanding Communication of Policy Goals"
  • 2005: Special Citation from the Director of the Center for Drug Evaluation and Research, "Exemplary Support in Responding to Congressional Inquires/Document Requests."
• Official Detail to FDA Chief Counsel Office (HHS Office of General Counsel, Food & Drug Division.) participated in litigation and counseling FDA Centers.
• Former researcher at the U.S. Army Center for Environmental Health Research, Ft. Detrich, Maryland.

• Executive Committee Member: Conference on Emerging Issues in Food and Drug Law: A National Conference for Lawyer, Policy-Makers, and Corporate Leaders at the University of Maryland School of Law (Program)
• Member: Food and Drug Law Institute (FDLI)
• Member: Food and Drug Alumni Association
• Member: DRI - The Voice of the Defense Bar
• Member: American Intellectual Property Law Association
• Member: American Bar Association
• Member: Maryland Bar Association
• Member: Federal Bar Association
• Alumnus / Former Vice Chair of Board of Directors: Maryland Student Legislature

• University of Maryland School of Law (J.D. 2008)
  
  • Phi Delta Phi International Legal Fraternity & Maryland Law Honor Society
• The George Washington University School of Business and Public Management (M.A. in Public Policy 2003)
  
• McDaniel College (B.A. 2001)
  
  • Mulhearn/Rhytter Undergraduate Leadership Award (one per class yearly)
  • 1999-2000 WMC Community Service Award for Distinguished Service
  • 2001 WMC Alumni Citizenship Award (Awarded to One Graduating Male)
  • Maryland Student Legislature (MSL): Governor, "Best Delegate" and "Best Delegation" Awards
  • Class of 2001, President 1997-2001, 2001 Student Government Assembly Leadership Award
  • Trumpeter (one of ten members of College's Leadership Honor Society)

• No Longer "If," But "When": The Coming Abbreviated Approval Pathway for Follow-on Biologics
  Published in the Food & Drug Law Journal (64 Food & Drug L. J., 115-148 (2009)) and posted with permission of FDLI.
  Spring 2009
  by Jeremiah J. Kelly and Michael David