Background Note | HBS Case Collection | 2007 (Revised from original 2007 version)
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;
Citation:
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 from original January 2007 version.)
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Course Overview Note | 2013 (Revised from original 2013 version)
The Entrepreneurial Manager: Course Overview, 2013 Winter Term
Richard G. Hamermesh, Richard G. Hamermesh and Thomas Eisenmann
Keywords: Entrepreneurship; Management; Business Education;
Case | HBS Case Collection | 2013 (Revised from original 2012 version)
Companion Diagnostics: Uncertainties for Approval and Reimbursement
Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
Keywords: models of reimbursement; personalized medicine; regulation; healthcare reform; Health Care and Treatment; Health Industry; United States;
Case | HBS Case Collection | 2012 (Revised from original 2011 version)
eHealthpoint: Healthcare for Rural India
Richard G. Hamermesh, Mona Sinha and Elizabeth Vrolyk
Keywords: Health Care and Treatment; Health Industry; India;