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January 2007 (Revised January 2007)
Background Note

Note on the U.S. Food and Drug Administration

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. View Details

Keywords: Health; Governance Compliance; Policy; Product Development; Government and Politics; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; Medical Devices and Supplies Industry; United States

Article

Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study

By: Noy Alon, Ariel Dora Stern and John Torous

BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous... View Details

Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile and Wireless Technology; Applications and Software; Framework

January–February 2021
Article

Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer

As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded... View Details

Keywords: Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards

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

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September 1996
Case

Food and Drug Administration: Business as Unusual at CDER

By: Steven C. Wheelwright and James Leonard

Keywords: Government Administration; Food and Beverage Industry; Food and Beverage Industry

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2021
Article

Public Health Risks Arising from Food Supply Chains: Challenges and Opportunities

By: Lu Chen, Donovan Guittieres, Retsef Levi, Elisabeth Paulson, Georgia Perakis, Nicholas Renegar and Stacy Springs

Safe, healthy, and resilient food supply chains are essential to ensuring the livelihood and well-being of humans and societies, as well as local and global economies. However, the ability to provide and sustain access to nutritious and safe food continues to be a... View Details

Keywords: Food Safety; Adulteration; Malnutrition; Supply Chain; Health; Government Administration; Food and Beverage Industry

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May 16, 2016
Article

Food Safety Economics: The Cost of a Sick Customer

By: Dina Gerdeman and John A. Quelch

Chipotle Mexican Grill’s ongoing struggle to win customers back months after a contaminated food crisis highlights the challenges companies face with keeping food safe.

Chipotle has seen its shares tumble and recently reported its first-ever quarterly loss... View Details

November 2009 (Revised March 2010)
Case

Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story

By: Richard G. Hamermesh, Raju Kucherlapati and Rachel Gordon

In May 2007, Amgen Inc. (Amgen) received disappointing news from the European Medicines Agency (EMEA) that its drug Vectibix, developed to fight metastatic colorectal cancer, had been rejected. This was especially surprising news given that a similar rival drug had... View Details

Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Marketing Strategy; Product Positioning; Genetics; Biotechnology Industry; Europe; United States

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... View Details

Keywords: Food; Supply and Industry; Food and Beverage Industry; Food and Beverage Industry; United States

February 2019 (Revised September 2019)
Case

Theranos: The Unicorn That Wasn't

By: Joseph B. Fuller and John Masko

In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains... View Details

Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry

2020
Working Paper

Fresh Fruit and Vegetable Consumption: The Impact of Access and Value

By: Retsef Levi, Elisabeth Paulson and Georgia Perakis

The goal of this paper is to leverage household-level data to improve food-related policies aimed at increasing the consumption of fruits and vegetables (FVs) among low-income households. Currently, several interventions target areas where residents have limited... View Details

Keywords: Food Deserts; Food Access; Food Policy; Causal Inference; Food; Nutrition; Poverty; Government Administration

28 Mar 2023
Research & Ideas

The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation

Early in the COVID-19 pandemic, the US Food and Drug Administration faced the task of convincing a skeptical public of the safety of new vaccines... View Details

Keywords: by Kasandra Brabaw; Pharmaceutical

2019
Working Paper

Optimal Interventions for Increasing Healthy Food Consumption Among Low Income Households

By: Retsef Levi, Elisabeth Paulson and Georgia Perakis

The federal government currently spends over $100 billion per year on policies aimed to increase fruit and vegetable (FV) consumption among low income households. These include price-, nutrition education-, and access-related interventions. Currently, the government... View Details

Keywords: Bi-level Optimization; Optimal Subsidies; Public Policy; Food Policy; Central Planner; Government Administration; Poverty; Food; Nutrition

15 Nov 2018
Book

Can the Global Food Industry Overcome Public Distrust?

JamesBrey Food is the largest segment of the global economy. It is also widely recognized as more critical for human health than any pharmaceutical drug on the planet. But significant changes in the industry are making people lose trust in many institutions involved in... View Details

Keywords: by Sean Silverthorne; Agriculture & Agribusiness

August 2020
Article

A History of Prescription Drug Monitoring Programs in the United States: Political Appeal and Public Health Efficacy

By: A Jay Holmgren, Alyssa Botelho and Allan M Brandt

Prescription drug monitoring programs (PDMPs) have become a widely embraced policy to address the US opioid crisis. Despite mixed scientific evidence on their effectiveness at improving health and reducing overdose deaths, 49 states and Washington, DC have adopted... View Details

Keywords: Health Disorders; Information Technology; Programs; Technology Adoption; History; Government and Politics; Policy; United States

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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... View Details

Keywords: Safety; Food; Health; Brands and Branding; Food and Beverage Industry; Food and Beverage Industry; United States

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12 Jun 2018
Research & Ideas

In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?

Papanikolaou, Kellogg School of Management. On balance, novel drugs with unproven chemical formulas are riskier to pursue because they are less likely to win approval from the US Food View Details

Keywords: by Rachel Layne; Health; Pharmaceutical

16 May 2016
HBS Case

Food Safety Economics: The Cost of a Sick Customer

Chipotle Mexican Grill’s ongoing struggle to win customers back months after a contaminated food crisis highlights the challenges companies face with keeping food safe. Chipotle has seen its shares tumble... View Details

Keywords: by Dina Gerdeman; Food & Beverage

November 1989
Teaching Note

H.J. Heinz Co.: The Administration of Policy (A), (B), (C), and (D), Teaching Note

By: Kenneth E. Goodpaster and Thomas R. Piper

Teaching Note for (9-382-034, 035, 036, and 037). View Details

Keywords: Business Earnings; Management Practices and Processes; Motivation and Incentives; System; Ethics; Policy; Business Divisions; Organizational Change and Adaptation; Food and Beverage Industry

January 2020
Case

Celata Bioinnovations

By: John R. Wells and Benjamin Weinstock

In December 2019, Jon Hu (HBS ‘19) and Dr. Samantha Dale Strasser, co-founders of Celata Bioinnovations, were raising $1 million to launch their company. They had founded Celata less than six months earlier with the aim of redefining the drug discovery process.... View Details

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