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- 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...
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- December 2022
- Article
'Just Letting You Know…': Underestimating Others' Desire for Constructive Feedback
People often avoid giving feedback to others even when it would help fix a problem immediately. Indeed, in a pilot field study (N=155), only 2.6% of individuals provided feedback to survey administrators that the administrators had food or marker on their faces....
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- September 2022
- Article
The Impact of Financial Assistance Programs on Health Care Utilization: Evidence from Kaiser Permanente
By: Alyce S. Adams, Raymond Kluender, Neale Mahoney, Jinglin Wang, Francis Wong and Wesley Yin
Most hospitals have financial assistance programs for low-income patients. We use administrative data from Kaiser Permanente to study the effects of financial assistance on health care utilization. Using a regression discontinuity design based on an income threshold...
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- June 9, 2023
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a...
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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...
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- 2021
- Working Paper
'Just Letting You Know…': Underestimating Others' Desire for Constructive Feedback
People often avoid giving feedback to others even when it would help fix a problem immediately. Indeed, in a pilot field study (N=155), only 2.6% of individuals provided feedback to survey administrators that the administrators had food or marker on their faces....
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Keywords:
Feedback;
Helping;
Prosocial Behavior;
Relationships;
Social Psychology;
Theory;
Perception
- 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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- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...
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- May 2021
- Case
The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease
By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra
This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory...
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- 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...
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- November 2020
- Teaching Note
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...
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- 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...
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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...
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- October 2020 (Revised June 2021)
- 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...
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Keywords:
Entrepreneurship;
Business Strategy;
Venture Capital;
Health Care and Treatment;
Health Disorders;
Leading Change;
Technology Adoption;
Digital Platforms;
Competitive Strategy;
Science;
Adaptation;
Corporate Social Responsibility and Impact;
Crisis Management;
Social Entrepreneurship;
Ethics;
Government Legislation;
Health;
Health Testing and Trials;
Health Pandemics;
Consumer Products Industry;
Health Industry;
Technology Industry;
Texas;
United States
- 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...
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Keywords:
Food Deserts;
Food Access;
Food Policy;
Causal Inference;
Food;
Nutrition;
Poverty;
Government Administration
- 2021
- Working Paper
Development of CAR-T Therapies: Case Histories of Significant Medical Advances
By: Amar Bhidé and Srikant M. Datar
In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works; 2) the foundational advances and discoveries; 3)...
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- 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...
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- May 2020 (Revised March 2022)
- Case
The Coronavirus (COVID-19) Pandemic and the Global Economy (A)
By: Alberto Cavallo and Christian Godwin
In April 2020, the world struggled to contain the exponential escalation of the coronavirus (COVID-19) pandemic. Dozens of countries had imposed restrictions on travel, work, and social gatherings. A large share of the global population was under lockdowns and...
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Keywords:
COVID-19 Pandemic;
Demand and Consumers;
Supply and Industry;
Finance;
Central Banking;
Financial Markets;
International Finance;
Globalization;
Government and Politics;
Health Pandemics;
Decision Making;
Macroeconomics;
Employment;
Crisis Management;
Supply Chain;
Risk and Uncertainty;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Asia;
China;
Europe;
Latin America;
Africa;
United States
- 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...
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- January 2020
- Article
The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System
By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...
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