Filter Results:
(365)
Show Results For
- All HBS Web (365)
- Faculty Publications (214)
Show Results For
- All HBS Web (365)
- Faculty Publications (214)
- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices... View Details
Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- 2022
- Article
Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios
By: Michael Iselin, Jung Koo Kang and Joshua Madsen
In their implementation of Basel III, U.S. bank regulators are again including changes in the fair value of available-for-sale (AFS) debt securities in Tier 1 capital, but only for the largest U.S. banks. This paper investigates a potential impact of expanding this... View Details
Keywords: Fair Value Accounting; SFAS 115; Basel III; Governing Rules, Regulations, and Reforms; Banks and Banking; Debt Securities; Credit; Risk and Uncertainty; Investment Portfolio; Decision Making; Banking Industry; United States
Iselin, Michael, Jung Koo Kang, and Joshua Madsen. "Regulatory Treatment of Changes in Fair Value and the Composition of Banks' Investment Portfolios." Journal of Financial Reporting 7, no. 1 (2022): 123–143.
- August 1984
- Case
Work of a Regulatory Agency: The EPA and Toxic Substances (Condensed)
By: Joseph L. Bower
Bower, Joseph L. "Work of a Regulatory Agency: The EPA and Toxic Substances (Condensed)." Harvard Business School Case 385-063, August 1984.
- 2003
- Chapter
Regulatory Laws and Political Culture in the United States and Germany
By: Arthur A. Daemmrich
- 2008
- Chapter
Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation
By: Arthur A. Daemmrich
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details
Keywords: Geographic Location; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Demand and Consumers; Pharmaceutical Industry; European Union; Germany; United States
Daemmrich, Arthur A. "Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation." Chap. 16 in Ways of Regulating: Therapeutic Agents between Plants, Shops, and Consulting Rooms. Vol. 363, edited by Jean Paul Gaudillière and Volker Hess, 271–290. Berlin, Germany: Max-Planck-Institut für Wissenschaftsgeschichte, 2008.
- 2009
- Working Paper
Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location
By: Arthur Daemmrich
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Health Testing and Trials; Power and Influence; Competitive Strategy; Pharmaceutical Industry; European Union; Germany; United States
Daemmrich, Arthur. "Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location." Harvard Business School Working Paper, No. 09-118, April 2009.
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging... View Details
Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- Article
Perceptions and the Politics of Finance: Junk Bonds and the Regulatory Seizure of First Capital Life
By: S. C. Gilson, H. DeAngelo and L. DeAngelo
In May 1991, one month after seizing Executive Life, California regulators seized First Capital Life (FCLIC). Both insurers were Drexel clients with large junk bond holdings, and both had experienced 'bank runs.' FCLIC's run followed regulators' televised comments that... View Details
Gilson, S. C., H. DeAngelo, and L. DeAngelo. "Perceptions and the Politics of Finance: Junk Bonds and the Regulatory Seizure of First Capital Life." Journal of Financial Economics 41, no. 3 (July 1996): 475–511.
- Article
Lords of the Harvest: Symbolic Signaling and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt and Sangchan Park
Hiatt, Shon R., and Sangchan Park. "Lords of the Harvest: Symbolic Signaling and Regulatory Approval of Genetically Modified Organisms." Academy of Management Annual Meeting Proceedings (2010).
- Oct 2010
- Conference Presentation
How Stringent Is Private Regulatory Monitoring? The Role of Organizational Scope and Governance
- 09 May 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- 10 May 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- July 2011
- Article
Bringing Ethics into Focus: How Regulatory Focus and Risk Preferences Influence (Un)ethical Behavior
By: F. Gino and Joshua D. Margolis
Gino, F., and Joshua D. Margolis. "Bringing Ethics into Focus: How Regulatory Focus and Risk Preferences Influence (Un)ethical Behavior." Organizational Behavior and Human Decision Processes 115, no. 2 (July 2011): 145–156.
- spring 1976
- Article
Information, Politics and Economic Analysis: The Regulatory Decision Process in the Air Freight Cases
By: M. E. Porter and J. F. Sagansky
Keywords: Information; Government and Politics; Economics; Governing Rules, Regulations, and Reforms; Decision Making
Porter, M. E., and J. F. Sagansky. "Information, Politics and Economic Analysis: The Regulatory Decision Process in the Air Freight Cases." Public Policy 24, no. 2 (spring 1976): 263–307.
- Oct 2010
- Conference Presentation
How Stringent Is Private Regulatory Monitoring? The Role of Organizational Scope and Governance
- 7 Nov 2010
- Conference Presentation
How Stringent Is Private Regulatory Monitoring? The Role of Organizational Scope and Governance
- 1 May 2010
- Conference Presentation
How Stringent is Private Regulatory Enforcement? The Role of Organizational Scope and Governance
- 15 Apr 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- November 2012 (Revised January 2013)
- Case
Companion Diagnostics: Uncertainties for Approval and Reimbursement
By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory... View Details
Keywords: Models Of Reimbursement; Personalized Medicine; Regulation; Healthcare Reform; Health Care and Treatment; Health Industry; United States
Hamermesh, Richard G., Norman C. Selby, and Phillip Andrews. "Companion Diagnostics: Uncertainties for Approval and Reimbursement." Harvard Business School Case 813-037, November 2012. (Revised January 2013.)