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- Faculty Publications (214)
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- All HBS Web (365)
- Faculty Publications (214)
- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel D. Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details
Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- 2005
- Chapter
Environmental Federalism in the European Union and the United States
By: David Vogel, Michael W. Toffel and Diahanna Post
The United States (US) and the European Union (EU) are federal systems in which the responsibility for environmental policy-making is divided or shared between the central government and the (member) states. The attribution of decision-making power has important policy... View Details
Keywords: Governing Rules, Regulations, and Reforms; Policy; Government Legislation; Natural Environment; Pollutants; Climate Change; European Union; United States
Vogel, David, Michael W. Toffel, and Diahanna Post. "Environmental Federalism in the European Union and the United States." Chap. 9 in A Handbook of Globalisation and Environmental Policy: National Government Interventions in a Global Arena, edited by F. Wijen, K. Zoeteman, and J. Pieters, 247–276. Cheltenham, U.K.: Edward Elgar Publishing, 2005.
- July 2000 (Revised April 2001)
- Case
Agricultural Biotechnology and its Regulation
In the United States, genetically modified corn and soybeans are now widely grown and consumed. In Europe, however, they have been dubbed "Frankenstein foods," shunned by packaged food manufacturers, and subjected to a host of governmental restrictions. This case... View Details
Keywords: Agribusiness; Genetics; Governing Rules, Regulations, and Reforms; Corporate Strategy; Trade; Law; Goods and Commodities; Safety; Environmental Sustainability; Government and Politics; Agriculture and Agribusiness Industry; Biotechnology Industry; Europe; United States
Reinhardt, Forest L. "Agricultural Biotechnology and its Regulation." Harvard Business School Case 701-004, July 2000. (Revised April 2001.)
- 2012
- Chapter
Environmental Federalism in the European Union and the United States
By: David Vogel, Michael W. Toffel, Diahanna Post and Nazli Z. Uludere Aragon
The United States (US) and the European Union (EU) are federal systems in which the responsibility for environmental policy-making is divided or shared between the central government and the (member) states. The attribution of decision-making power has important policy... View Details
Keywords: Natural Environment; Policy; Government and Politics; Governing Rules, Regulations, and Reforms; European Union; United States
Vogel, David, Michael W. Toffel, Diahanna Post, and Nazli Z. Uludere Aragon. "Environmental Federalism in the European Union and the United States." Chap. 11 in A Handbook of Globalisation and Environmental Policy. 2nd ed. Edited by Frank Wijen, Kees Zoeteman, Jan Pieters, and Paul van Seters, 321–361. Cheltenham, UK, 2012.
- 12 Jul 2006
- Research & Ideas
Competition the Cure for Healthcare
D. Anderson Cancer Center, and Dartmouth Hitchcock Medical Center, which are moving toward results measurement and integrated practice unit structures. Reforming the U.S. system does not require a top down, big bang, government-led View Details
- 2020
- Working Paper
Capital Regulation and Product Market Outcomes
By: Ishita Sen and David Humphry
We present evidence of product market adjustments and asset reorganizations from the largest ever shift in risk regulation in a developed insurance market. Using proprietary data on insurance risk exposures from the Bank of England, we develop a measure of regulatory... View Details
Keywords: Non-traditional-non-insurance; Risk Regulation; Product Market Concentration; Small Vs. Large Insurers; Insurance Risk Exposure; Insurance; Risk and Uncertainty; Governing Rules, Regulations, and Reforms
Sen, Ishita, and David Humphry. "Capital Regulation and Product Market Outcomes." Working Paper, January 2020.
- February 2016 (Revised March 2017)
- Case
Regulating Radio in the Age of Broadcasting
By: David Moss, Marc Campasano and Colin Donovan
When the Titanic tragically sank on April 15, 1912, potentially life-saving help was delayed as a result of failures in radio communication. In part as a result, Congress moved swiftly to regulate radio, passing the Radio Act of 1912 four months later. Although at... View Details
Keywords: Radio; Regulation; Communication Technology; Government Legislation; History; Media and Broadcasting Industry; United States
Moss, David, Marc Campasano, and Colin Donovan. "Regulating Radio in the Age of Broadcasting." Harvard Business School Case 716-043, February 2016. (Revised March 2017.)
- 2007
- Book
Perspectives on Risk and Regulation: The FDA at 100
By: Arthur A. Daemmrich and Joanna Radin
Perspectives on Risk and Regulation: The FDA at 100 brings together the viewpoints of Food and Drug Administration officials and industry leaders on the future of regulating food, drugs, medical devices, and dietary supplements. In a period of rapid scientific... View Details
Keywords: Private Sector; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Business and Government Relations; Risk and Uncertainty; Cooperation
Daemmrich, Arthur A., and Joanna Radin, eds. Perspectives on Risk and Regulation: The FDA at 100. Chemical Heritage Foundation, 2007. (Fulltext.)
- December 1992 (Revised November 1993)
- Exercise
Negotiation Exercise on Tradeable Pollution Allowances: Group C, Utility #3
Describes the position of Utility #3 in negotiating Group C with respect to 1) its SO emissions reduction requirements; 2) the costs of its alternative compliance strategies; and 3) the nature of its state regulatory environment. View Details
Keywords: Negotiation Participants; Negotiation Process; Pollutants; Laws and Statutes; Governing Rules, Regulations, and Reforms; Governance Compliance; Utilities Industry; United States
Emmons, Willis M., III. "Negotiation Exercise on Tradeable Pollution Allowances: Group C, Utility #3." Harvard Business School Exercise 793-083, December 1992. (Revised November 1993.)
- December 1992
- Exercise
Negotiation Exercise on Tradeable Pollution Allowances: Group B, Utility #1
Describes the position of Utility #1 in negotiating Group B with respect to 1) its SO emissions reduction requirements; 2) the costs of its alternative compliance strategies; and 3) the nature of its state regulatory environment. View Details
Keywords: Decision Choices and Conditions; Governance Compliance; Governing Rules, Regulations, and Reforms; Government Legislation; Negotiation; Pollutants; Strategy; Utilities Industry
Emmons, Willis M., III. "Negotiation Exercise on Tradeable Pollution Allowances: Group B, Utility #1." Harvard Business School Exercise 793-077, December 1992.
- 20 Apr 2021
- Working Paper Summaries
The Emergence of Mafia-like Business Systems in China
Keywords: by Meg Rithmire and Hao Chen
- December 1992
- Exercise
Negotiation Exercise on Tradeable Pollution Allowances: Group A, Utility #1
Describes the position of Utility #1 in negotiating Group A with respect to 1) its SO emissions reduction requirements; 2) the costs of its alternative compliance strategies; and 3) the nature of its state regulatory environment. View Details
Keywords: Negotiation Participants; Negotiation Process; Pollutants; Laws and Statutes; Governing Rules, Regulations, and Reforms; Governance Compliance; Utilities Industry; United States
Emmons, Willis M., III. "Negotiation Exercise on Tradeable Pollution Allowances: Group A, Utility #1." Harvard Business School Exercise 793-073, December 1992.
- September 2024
- Case
Comun: Partners in Peril
By: Jeffrey J. Bussgang and Alexis Lefort
In spring 2023, Abiel Gutierrez and Andres Santos, co-founders of Comun, faced a critical decision at their fintech startup serving Latino immigrants. Having launched their product the previous year, they experienced rapid growth but encountered rising fraud and... View Details
- December 2009 (Revised June 2010)
- Supplement
Goldman Sachs: A Bank for All Seasons (B)
By: Lena G. Goldberg and Tiffany Lynne Obenchain
Having taken steps to shore up investor confidence, during the turbulent fourth quarter of 2008, Goldman Sachs confronts the challenge of whether its business model will continue to be viable under radically altered market conditions and a new regulatory regime. View Details
Keywords: Business Model; Financial Crisis; Investment Banking; Financial Management; Financial Strategy; Governing Rules, Regulations, and Reforms; Business Strategy; Banking Industry
Goldberg, Lena G., and Tiffany Lynne Obenchain. "Goldman Sachs: A Bank for All Seasons (B)." Harvard Business School Supplement 310-056, December 2009. (Revised June 2010.)
- August 2001
- Case
Scios, Inc.
Scios, filled with distinguished scientists and experienced managers, nevertheless fails to clear the FDA Phase III process for an important biotechnology drug. This case asks the students to analyze the social costs and benefits of the regulatory process. View Details
- November 2023 (Revised March 2024)
- Technical Note
Customer Data Privacy
By: Eva Ascarza and Ta-Wei Huang
This note provides an overview of the evolving landscape of customer data privacy in 2023. It highlights two pivotal aspects that make privacy a central concern for businesses: building and maintaining customer trust and navigating the intricate regulatory... View Details
Keywords: Customer Relationship Management; Governance Compliance; Governing Rules, Regulations, and Reforms; Risk and Uncertainty; Reputation; Trust; Information Management; Retail Industry; Technology Industry; Financial Services Industry; Telecommunications Industry; Europe; United States
Ascarza, Eva, and Ta-Wei Huang. "Customer Data Privacy." Harvard Business School Technical Note 524-005, November 2023. (Revised March 2024.)
- May 2008
- Article
Coerced Confessions: Self-Policing in the Shadow of the Regulator
By: Jodi L. Short and Michael W. Toffel
As part of a recent trend toward more cooperative relations between regulators and industry, novel government programs are encouraging firms to monitor their own regulatory compliance and voluntarily report their own violations. In this study, we examine how regulatory... View Details
Keywords: Governance Compliance; Law Enforcement; Corporate Disclosure; Governing Rules, Regulations, and Reforms; Environmental Sustainability; Programs; Power and Influence; Organizations; Decisions; Business and Government Relations; United States
Short, Jodi L., and Michael W. Toffel. "Coerced Confessions: Self-Policing in the Shadow of the Regulator." Journal of Law, Economics & Organization 24, no. 1 (May 2008): 45–71.
- 14 Dec 2010
- Working Paper Summaries
Regulating for Legitimacy: Consumer Credit Access in France and America
Keywords: by Gunnar Trumbull
- March 2012
- Article
How to Make Finance Work
By: Robin Greenwood and David S. Scharfstein
Once a sleepy old boys' club, the U.S. financial sector is now a dynamic and growing business that attracts the best and the brightest. It is tempting to declare the industry a roaring success. But its purpose is to serve the needs of U.S. households and firms, and by... View Details
Keywords: Business Ventures; Value; Competitive Advantage; Investment; Performance Evaluation; Household; Financial Crisis; Finance; Financial Services Industry; United States
Greenwood, Robin, and David S. Scharfstein. "How to Make Finance Work." Harvard Business Review 90, no. 3 (March 2012).
- 2012
- Other Unpublished Work
Environmental corporate strategy and advancements in enhanced oil recovery technology among U.S. firms
By: Shon R. Hiatt
This study seeks to address how collective actors can affect technology development and adoption among organizations by creating regulatory uncertainty. Empirically, this paper focuses on the influence of environmental organizations concerned about climate change on... View Details