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- All HBS Web (144)
- Faculty Publications (33)
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- All HBS Web (144)
- Faculty Publications (33)
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- January 2014 (Revised June 2014)
- Case
23andMe: Genetic Testing for Consumers (A)
By: John A. Quelch and Margaret L. Rodriguez
On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was...
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Keywords:
Public Health;
Genome Testing;
Health Care;
Ancestry;
23andMe;
Marketing;
Product Launch;
Health;
Health Care and Treatment;
Health Testing and Trials;
Genetics;
Strategy;
Health Industry;
United States
Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
- 2010
- Chapter
From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance
By: Arthur A. Daemmrich
Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Business and Government Relations;
Risk and Uncertainty;
Safety;
Pharmaceutical Industry;
United States
Daemmrich, Arthur A. "From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance." Chap. 13 in The Fragmentation of U.S. Health Care: Causes and Solutions, edited by Einer Elhauge, 301–322. Oxford: Oxford University Press, 2010.
- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
- November 2008 (Revised July 2009)
- Background Note
A Managerial Perspective on Clinical Trials
By: Arthur A. Daemmrich
This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Product Development;
Safety;
Biotechnology Industry;
Pharmaceutical Industry
Daemmrich, Arthur A. "A Managerial Perspective on Clinical Trials." Harvard Business School Background Note 709-033, November 2008. (Revised July 2009.)
- 2016
- Working Paper
Standardized Color in the Food Industry: The Co-Creation of the Food Coloring Business in the United States, 1870–1940
By: Ai Hisano
This working paper examines how, starting in the 1870s, food manufacturers in the United States began to use standardized color, achieved by synthetic dyes, as part of their marketing strategies. Food manufacturers along with dye makers and regulators co-created the...
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Keywords:
Food;
Supply and Industry;
Manufacturing Industry;
Food and Beverage Industry;
United States
Hisano, Ai. "Standardized Color in the Food Industry: The Co-Creation of the Food Coloring Business in the United States, 1870–1940." Harvard Business School Working Paper, No. 17-037, October 2016.
- 10 Aug 2015
- Research & Ideas
New Medical Devices Get To Patients Too Slowly
While the US Food and Drug Administration has chiseled away pharmaceutical review times over the years to speed innovative drugs to market, the opposite seems to have occurred in the agency's approval of...
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- Article
The Rise of Synthetic Colors in the American Food Industry, 1870–1940
By: Ai Hisano
This article examines how, starting in the 1870s, food manufacturers in the United States began to use standardized color, achieved by synthetic dyes, as part of their marketing strategies. The emergence of the synthetic dye industry paralleled the growth of mass...
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Keywords:
Safety;
Food;
Health;
Brands and Branding;
Manufacturing Industry;
Food and Beverage Industry;
United States
Hisano, Ai. "The Rise of Synthetic Colors in the American Food Industry, 1870–1940." Special Issue on Food and Agriculture. Business History Review 90, no. 3 (October 2016): 483–504.
- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
Keywords:
Digital;
Medicine;
FDA;
Health Care and Treatment;
Applications and Software;
Safety;
Cybersecurity;
Medical Devices and Supplies Industry
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
- 22 Apr 2009
- Working Paper Summaries
Where is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location
- 2007
- Article
Pharmacovigilance and the Missing Denominator: The Changing Context of Pharmaceutical Risk Mitigation
By: Arthur A. Daemmrich
In the wake of Vioxx, Avandia, and other recent prominent cases of drugs found to cause side effects after marketing, the safety of pharmaceuticals has come to the forefront of American public policy. Press attention, congressional investigations, and legislative...
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Keywords:
Brands and Branding;
Policy;
Risk Management;
Government Legislation;
Risk and Uncertainty;
Goals and Objectives;
Customers;
Pharmaceutical Industry;
Health Industry;
United States
Daemmrich, Arthur A. "Pharmacovigilance and the Missing Denominator: The Changing Context of Pharmaceutical Risk Mitigation." Pharmacy in History 49, no. 2 (2007): 61–75.
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- 18 Dec 2018
- First Look
New Research and Ideas, December 18, 2018
2018 Innovation Policy and the Economy The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century By: Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern Abstract—On the 35th...
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Keywords:
Dina Gerdeman
- 2023
- Working Paper
The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina
By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle
We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed...
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Keywords:
COVID-19;
Health Care and Treatment;
Health Pandemics;
Adoption;
Behavior;
Governing Rules, Regulations, and Reforms;
Learning
Calónico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina." NBER Working Paper Series, No. 31781, October 2023.
- 23 Apr 2014
- HBS Case
Are Electronic Cigarettes a Public Good or Health Hazard?
make "vapes" attractive to children. Some states and cities responded with restrictions on sales and advertising, and, in April, the Financial Times reported that the World Health Organization will call for e-cigarettes to be View Details
- 07 Dec 2010
- First Look
First Look: Dec. 7
commit to providing EV reports. Moreover, I document that EV reporting is more widespread in countries with more hostile takeovers, managers that do not avoid volatile income measures, regulators that are less likely to intervene in the...
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Keywords:
Sean Silverthorne
- 04 Sep 2018
- First Look
New Research and Ideas, September 4, 2018
It subsequently became much more arduous for pharmaceutical firms to bring new drugs to market. Some critics therefore argued that the new regulations were actually detrimental, as they prevented or delayed...
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Keywords:
Dina Gerdeman
- 11 Jan 2017
- Research & Ideas
The Paradoxical Quest to Make Food Look 'Natural' With Artificial Dyes
chromate was used to make milk look creamier; and various poisonous ingredients were used to create bright colors for various candies, reportedly causing some children to fall ill or even die. Hisano highlights key dates in food coloring View Details
Keywords:
by Carmen Nobel
- 24 Sep 2007
- Research & Ideas
The FDA: What Will the Next 100 Years Bring?
The U.S. Food and Drug Administration, which was created by the passage of the 1906 Federal Food and Drugs Act, regulates companies and industries accounting for one-quarter of...
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- 12 Jul 2016
- First Look
July 12, 2016
Case 816-005, "Bigbelly," by Mitchell Weiss and Christine Snively. This case is an example of public entrepreneurship. Publisher's link: https://pubwww.hbs.edu/faculty/Pages/item.aspx?num=51306 Financial Regulation in a Quantitative Model of...
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Keywords:
Sean Silverthorne
- Teaching Interest
Overview
By: Leemore S. Dafny
U.S. Healthcare Strategy
The U.S. healthcare sector accounts for 17 percent of GDP, and encompasses a diverse set of industries with public, nonprofit, and for-profit buyers and sellers. There are significant concerns about high and rising spending, and...
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