Background Note | HBS Case Collection | January 2007 (Revised January 2007)

Note on the U.S. Food and Drug Administration

by Robert F. Higgins, Richard G. Hamermesh and Virginia Fuller


Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure.

Keywords: Health; Governance Compliance; Policy; Product Development; Government and Politics; Pharmaceutical Industry; Medical Devices and Supplies Industry; Biotechnology Industry; Public Administration Industry; United States;


Higgins, Robert F., Richard G. Hamermesh, and Virginia Fuller. "Note on the U.S. Food and Drug Administration." Harvard Business School Background Note 807-050, January 2007. (Revised January 2007.)