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- September 1991 (Revised August 1994)
- Background Note
Note on Pharmaceutical Industry Regulation
Traces the evolution of U.S. regulatory policy towards the pharmaceutical industry over the course of the twentieth century. A major theme is the steady shift away from a policy of 'let the buyer beware' to the creation of a complex and time-consuming review process,...
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Keywords:
Safety;
Industry Growth;
Marketing;
Research and Development;
Health Testing and Trials;
Economics;
Pharmaceutical Industry;
United States
Emmons, Willis M., III. "Note on Pharmaceutical Industry Regulation." Harvard Business School Background Note 792-002, September 1991. (Revised August 1994.)
- Forthcoming
- Article
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern
Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to...
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Keywords:
Innovation and Invention;
Governing Rules, Regulations, and Reforms;
Government Administration;
Research and Development;
Pharmaceutical Industry
Chandra, Amitabh, Jennifer Kao, Kathleen L. Miller, and Ariel Dora Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." Review of Economics and Statistics (forthcoming). (Pre-published online March 18, 2024.)