Food And Drug Administration - Publications - Faculty & Research - Harvard Business School

Filter Results: (37)

Filter Results: (37)

Show Results For

← Page 2 of 37 Results

Are you looking for?

→Search All HBS Web

May 25, 2016
Comment

How Consumers and Businesses are Reshaping Public Health

By: John A. Quelch

Healthcare and education are two issues in which citizens around the world, rich and poor, are passionately interested. It has long been appreciated that the way that a society treats its youngest and oldest members says much about its moral maturity. Economic... View Details

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

January 2015 (Revised July 2019)
Case

Rebranding Godiva: The Yıldız Strategy

By: Rohit Deshpande and Esel Çekin

This case concerns Yıldız Holding’s acquisition of Godiva Chocolatier from its previous owner, Campbell Soup, and its salient strategy in preserving Godiva’s “made in Belgian” brand position. Provenance Paradox, a problem faced by companies in emerging countries trying... View Details

Keywords: Branding; Internationalization; Provenance Paradox; Acquisitions; Positioning; Innovation; Customer-centricity; Brands and Branding; Marketing Strategy; Emerging Markets; Product Positioning; Change Management; Innovation and Management; Customer Focus and Relationships; Food and Beverage Industry; North America; Turkey; Japan

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... View Details

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

September 2013 (Revised August 2015)
Background Note

Leadership and Teaming

By: Ethan Bernstein

Small differences in the leadership of teams can have large consequences for the success of their efforts. Many initiatives fail not because of a fatal error in judgment or insufficient ideas, knowledge, motivation, or capabilities to deliver a solution. They fail... View Details

Keywords: Teams; Teaming; Leadership And Managing People; Leadership; Team Effectiveness; Team Performance; Team Design; Team Leadership; Teamwork; Team Process; Team Function; Team Launch; 60/30/10 Rule; Team Boundary; Distribution Of Leadership Authority; Self-Managed Teams; Virtual Teams; Unbounded Teams; Acts Of Leadership; Execution Teams; Decision Making Teams; Creativity Teams; Team Size; Task Design; Team Timeline; Team Roles; Team Representation; Diversity; Team Familiarity; Collective Intelligence; Team Stages Of Development; Team Coaching; Performance Pressure; X-Teams; Team Focus; Interaction; Management Teams; Managerial Roles; Management Systems; Management Style; Management Skills; Management Practices and Processes; Organizational Design; Organizational Structure; Performance Effectiveness; Performance Efficiency; Performance Productivity; Groups and Teams; Networks; Social Psychology; Behavior; Conflict and Resolution; Creativity; Social and Collaborative Networks; Satisfaction; Prejudice and Bias; Power and Influence; Personal Characteristics; Familiarity; Cognition and Thinking; Attitudes; Projects; Organizational Culture; Organizational Change and Adaptation; Leadership Development; Leadership Style; Leading Change; Knowledge Use and Leverage; Knowledge Sharing; Collaborative Innovation and Invention; Innovation and Management; Innovation Leadership; Design; Interpersonal Communication; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Asia; North and Central America; South America; Atlantic Ocean; Central Asia; Europe; Latin America; Middle East; Oceania; West Indies

November 2010
Supplement

Hikma Pharmaceuticals (B)

By: John A. Quelch

By 2009, Hikma Pharmaceuticals operated 13 manufacturing plants in 8 countries of which 5 were approved by the U.S. Food and Drug Administration. Hikma tracked its sales revenues over the period to show where the largest contributors were from. View Details

Keywords: Strategy; Knowledge Use and Leverage; Sales; Pharmaceutical Industry

November 2009 (Revised March 2013)
Case

PureCircle

By: David E. Bell and Aldo Sesia

In December 2008, the U.S. Food and Drug Administration (FDA) determined that high-purity Rebaudioside A (Reb A), a natural and calorie-free product that a young company named PureCircle manufactured from the Stevia plant, could be used in beverages, foods, and as a... View Details

Keywords: Customer Relationship Management; Investment; Globalization; Leadership; Risk Management; Product Launch; Production; Performance Productivity; Business and Shareholder Relations; Food and Beverage Industry; United States

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

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

November 2000 (Revised March 2001)
Case

Iggy's Bread of the World

By: Kathleen L. McGinn and Alexis Lefort

In January 1994, Igor and Ludmilla Ivanovic opened the doors of their bakery, Iggy's Bread of the World. This case describes their unusual mission statement and the way in which they try to bring a social consciousness mentality to a for-profit business. Six years... View Details

Keywords: Growth Management; Mission and Purpose; Organizational Culture; Restructuring; Family Business; Power and Influence; Food and Beverage Industry; Food and Beverage Industry; Massachusetts

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

Find at Harvard

November 1993 (Revised January 2006)
Supplement

Beech-Nut Nutrition Corporation (B)

By: Lynn S. Paine

Officials of the U.S. Food and Drug Administration (FDA) must decide whether to refer the Beech-Nut apple juice case to the Justice Department for criminal prosecution, and if so, whether to recommend prosecution of individual executives or of the company only. View Details

Keywords: Crime and Corruption; Decisions; Cases; Law; Management; Food and Beverage Industry

September 1991 (Revised August 1994)
Background Note

Note on Pharmaceutical Industry Regulation

By: Willis M. Emmons III

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,... View Details

Keywords: Safety; Industry Growth; Marketing; Research and Development; Health Testing and Trials; Economics; Pharmaceutical Industry; United States

Find at Harvard

September 1991 (Revised February 1993)
Case

Burroughs Wellcome and AZT (A)

By: Willis M. Emmons III

Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S.... View Details

Keywords: Governing Rules, Regulations, and Reforms; Ethics; Business and Government Relations; Communication Strategy; Health Care and Treatment; Monopoly; Intellectual Property; Research and Development; Price; Pharmaceutical Industry; London

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

Research Summary

Overview

By: Brian L. Trelstad

The focus of my research is on the systems of social innovation. How small groups of individuals come up with new products and services targeting important problems; how they finance these initial efforts, and convert prototypes into viable organizational strategies;... View Details

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... View Details

Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry

Find at Harvard

Register to Read

←
1
2