Food And Drug Administration - Publications - Faculty & Research

2024
Working Paper

Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions

By: Caleb Kwon, Ananth Raman and Jorge Tamayo

We investigate whether corporate officers should grant managers discretion to override AI-driven demand forecasts and labor scheduling tools. Analyzing five years of administrative data from a large grocery retailer using such an AI tool, encompassing over 500 stores,... View Details

Keywords: AI and Machine Learning; Forecasting and Prediction; Working Conditions; Performance Productivity

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2024
Article

Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway

By: Mateo Aboy, Cristina Crespo and Ariel Stern

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States

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November 2020
Case

Valuing Celgene's CVR

By: Benjamin C. Esty and Daniel Fisher

When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage... View Details

Keywords: Mergers and Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States

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01 Apr 2014
News

FDA Moves to Regulate E-Cigarettes

25 Sep 2018
First Look

New Research and Ideas, September 25, 2018

operations. Product failures are, therefore, likely to impact firms’ subsequent innovation activities. Using 13 years of Food and Drug View Details

Keywords: Dina Gerdeman

November 2020
Supplement

Valuing Celgene's CVR

By: Benjamin C. Esty and Daniel Fisher

When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage... View Details

Keywords: Mergers and Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States

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October 2020 (Revised November 2023)
Case

COVID-19 Testing at Everlywell

By: Jeffrey J. Bussgang and Olivia Hull

In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the... View Details

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19 Dec 2017
First Look

New Research and Ideas, December 19, 2017

Abstract—No abstract available. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53633 Characterizing the Drug Development Pipeline for Precision Medicines By: Chandra, Amitabh, Craig Garthwaite, View Details

Keywords: Carmen Nobel

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

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31 Oct 2017
First Look

New Research and Ideas, October 31, 2017

developed new product categories such as organic food and wind and solar energy, which explicitly focused on sustainability. Again this process has been traced back to the... View Details

Keywords: by Sean Silverthorne

16 May 2022
News

Baby Formula Is Just the Latest Supply Chain Crisis—We Should Be Asking Why

01 Dec 2022
News

December 2022 Alumni and Faculty Books and Podcasts

Edited by Margie Kelley Alumni Books Pilgrimage to the Museum: Man’s Search for God Through Art and Time By Stephen Auth (MBA 1985) Sophia Institute Press In Pilgrimage to the Museum, author-curator Stephen Auth takes you on a colorful journey through the history of... View Details

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 View Details

Keywords: by Sean Silverthorne; Food & Beverage; Food & Beverage; Food & Beverage; Food & Beverage

01 Dec 2015
News

Leading Boston and Beyond

(MBA 2002), served as the city’s CFO from 2010 to 2014 after working as an advisor to the mayor and serving in the department of administration and finance. Mitch Weiss (MBA... View Details

Keywords: Jen Myers; Executive, Legislative, and Other General Government Support; Executive, Legislative, and Other General Government Support

23 Jun 2015
Video

Innovations Wanted: Beating Brain Disease

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

Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry

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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

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November 2020
Teaching Note

Valuing Celgene's CVR

By: Benjamin C. Esty and Daniel Fisher

Teaching Note for HBS Case No. 221-031. When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA)... View Details

Keywords: Mergers and Acquisitions; Valuation; Value; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States

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05 Dec 2017
First Look

First Look at New Research and Ideas, December 5, 2017

sales, marketing, and communication had made its yogurt a hit with consumers, and its entrepreneurial and innovative culture made it popular with its employees. But by 2012,... View Details

Keywords: Sean Silverthorne

November 2017
Case

The 'Wonder Drug' That Killed Babies

By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble

In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children... View Details