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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 (Revised January 2023)
- Case
Marfrig's Quest for Greener Beef
By: Jose B. Alvarez, Pedro Levindo and Ruth Costas
Marfrig, one of the world’s leading meatpackers, strived to comply with its commitment to have a deforestation-free value chain in Brazil by 2030. The company also pledged to reduce its emissions of greenhouse gases in accordance with the guidelines set by the...
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Keywords:
Agribusiness;
Animal-Based Agribusiness;
Plant-Based Agribusiness;
Acquisition;
Family Business;
Communication Strategy;
Environmental Management;
Climate Change;
Environmental Regulation;
Environmental Sustainability;
Bonds;
Food;
Global Strategy;
Goods and Commodities;
Government and Politics;
Political Elections;
Leading Change;
Marketing;
Product Marketing;
Product Positioning;
Supply Chain;
Supply Chain Management;
Corporate Social Responsibility and Impact;
Business and Government Relations;
Business and Stakeholder Relations;
Partners and Partnerships;
Strategy;
Adaptation;
Business Strategy;
Commercialization;
Competitive Strategy;
Corporate Strategy;
Diversification;
Expansion;
Agriculture and Agribusiness Industry;
Food and Beverage Industry;
Brazil;
Latin America;
Argentina;
Uruguay;
North America;
United States;
Europe;
Asia;
China
- December 2022
- Case
Iberdrola: Leading the Energy Revolution
By: Juan Alcácer and Emer Moloney
At the end of 2019, Ignacio Galán, the Chairman and CEO of the world's third largest utility, Iberdrola, relected on his almost 20 years at the company. He managed a portfolio of three very different businesses, each with their own specific opportunities and...
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Keywords:
Energy;
Energy Generation;
Energy Sources;
Non-Renewable Energy;
Renewable Energy;
Engineering;
Innovation and Management;
Innovation Leadership;
Innovation Strategy;
Technological Innovation;
Leadership;
Growth and Development Strategy;
Market Timing;
Industry Growth;
Mission and Purpose;
Strategy;
Energy Industry;
Green Technology Industry;
Utilities Industry;
Transportation Industry;
Auto Industry;
Spain;
United Kingdom;
United States;
Brazil;
Mexico
- December 2022 (Revised January 2023)
- Case
Cann: High Hopes for Cannabis Infused Beverages
By: Ayelet Israeli and Anne V. Wilson
Founded in 2018 by Jake Bullock and Luke Anderson, Cann sold “social tonics,” or cannabis-infused beverages. By 2022, the company had several notable celebrity investors and talent partners, had sold over 10 million beverages to consumers, was distributing in six...
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Keywords:
Stigma;
Product Innovation;
Product Introduction;
Product Differentiation;
New Products;
New Product Marketing;
New Product Management;
Brand Management;
Branding;
Packaging;
Positioning;
Growth Strategy And Execution;
Growth;
Cannabis Industry;
Purpose;
Purpose Brands;
LGBTQ;
Direct-to-consumer;
DTC;
Regulations;
Channels Of Distribution;
Product Development;
Product Marketing;
Product Positioning;
Product;
Innovation and Invention;
Brands and Branding;
Marketing;
Marketing Communications;
Marketing Channels;
Advertising;
Advertising Campaigns;
Digital Marketing;
Market Entry and Exit;
Governing Rules, Regulations, and Reforms;
Consumer Products Industry;
Food and Beverage Industry;
United States;
Canada;
North America
- December 2022
- Article
Competition, Contracts, and Creativity: Evidence from Novel Writing in a Platform Market
By: Yanhui Wu and Feng Zhu
A growing number of people today are participating in the gig economy, working as independent contractors on short-term projects. We study the effects of competition on gig workers' effort and creativity on a Chinese novel-writing platform. Authors produce and sell...
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- December 2022
- Article
Does Industry Employment of Active Regulators Weaken Oversight?
By: Jonas Heese
I study whether industry employment of active regulators weakens oversight. To examine this question, I exploit that the Financial Reporting Enforcement Panel (FREP), the German capital-market regulator responsible for enforcing public firms’ compliance with accounting...
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- 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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- December 2022
- Article
Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics
By: Cheng Gao and Rory McDonald
In nascent industries—whose new technologies are often poorly understood
by regulators—contending with regulatory uncertainty can be crucial to organizational survival and growth. Prior research on nonmarket strategy has largely
focused on established firms in mature...
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- 2022
- Working Paper
The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives
By: Ariel Dora Stern
For those who follow health and technology news, it is difficult to go more than a few days without reading about a compelling new application of Artificial Intelligence (AI) to health care. AI has myriad applications in medicine and its adjacent industries, with...
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- November 2022 (Revised December 2022)
- Case
Replika AI: Monetizing a Chatbot
By: Julian De Freitas and Nicole Tempest Keller
In early 2018, Eugenia Kuyda, co-founder and CEO of San Francisco-based chatbot Replika AI, was deciding how to monetize the app she had built. Launched in 2017, Replika was a consumer AI “companion app” developed by a team of AI software engineers originally based in...
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- November 2022 (Revised December 2022)
- Supplement
JUUL and the Vaping Revolution: A 2022 Update
By: Michael W. Toffel and Sarah Mehta
This slide deck provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.
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Keywords:
Electronic Cigarettes;
E-Cigarettes;
Vaping;
Nicotine Replacement;
JUUL;
Juuling;
Government Regulation;
Advertising;
Advertising Campaigns;
Digital Marketing;
Customers;
Innovation and Invention;
Innovation Strategy;
Marketing;
Ethics;
Brands and Branding;
Marketing Communications;
Marketing Strategy;
Product Marketing;
Corporate Social Responsibility and Impact;
Social Issues;
Technology Industry;
California
- November 2022 (Revised December 2022)
- Supplement
JUUL and the Vaping Revolution: A 2022 Update
By: Michael W. Toffel and Sarah Mehta
This case provides a brief update (2019-2022) on the rise and fall of JUUL Labs, the maker of the popular JUUL e-cigarette.
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Keywords:
Electronic Cigarettes;
E-Cigarettes;
Vaping;
Nicotine Replacement;
JUUL;
Juuling;
Government Regulation;
Advertising;
Advertising Campaigns;
Digital Marketing;
Customers;
Innovation and Invention;
Innovation Strategy;
Marketing;
Ethics;
Brands and Branding;
Marketing Communications;
Marketing Strategy;
Product Marketing;
Corporate Social Responsibility and Impact;
Social Issues;
Technology Industry;
California
- October 21, 2022
- Article
Climate Regulations Are About to Disrupt Global Shipping
By: Willy C. Shih
Ships that transport goods across oceans are collectively a major generator of greenhouse gases. Rules from the International Maritime Organization and the European Union aimed at curbing these emission promise to make transoceanic and regional shipping more expensive...
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- October 17, 2022
- Article
When Climate Collaboration Is Treated as an Antitrust Violation
By: Matteo Gasparini, Knut Haanaes and Peter Tufano
Carbon emissions transcend firms and borders—they are a massive, unpriced externality. Companies across industries are increasingly waking up to the need to cooperate in the fight against climate change but the law might get in the way. Across Europe and the U.S.,...
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- October 2022
- Background Note
Note on Cyberattacks and Regulatory Regimes
Describes common types of cyberattacks on enterprises and their costs, as well as the fragmentary regulatory regimes through which U.S. states and regulatory agencies at the start of 2021 attempted to encourage disclosure of cyberattacks and to pursue enforcement...
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- September 2022 (Revised December 2022)
- Case
Navya: Steering Toward a Driverless Future
By: Julian De Freitas, Elie Ofek, Shaun Ingledew and Tonia Labruyere
In 2022, Sophie Desormière arrived at French roboshuttle producer Navya, tasked with charting a new course in a challenging sector. The company, which had recently listed on the Paris Stock Exchange, was burning through cash reserves and needed to transform the promise...
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- September 2022
- Case
BancoSol: Financial Inclusion in the Perfect Storm
By: Michael Chu and Carla Larangeira
In the pandemic, financial inclusion icon BancoSol faces a government-mandated year-long deferral of all loan payments, followed by the sudden Covid death of its CEO. In a Bolivia mired in political turmoil following a failed presidential election, with clients not...
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- 2022
- Article
Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response
By: Alexander MacKay and Samuel N. Weinstein
Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate...
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Keywords:
Competition Policy;
Regulation;
Algorithmic Pricing;
Dynamic Pricing;
Economics;
Law And Economics;
Law And Regulation;
Consumer Protection;
Antitrust Law;
Industrial Organization;
Antitrust Issues And Policies;
Technological Change: Choices And Consequences;
Competition;
Policy;
Price;
Governing Rules, Regulations, and Reforms;
Microeconomics;
Duopoly and Oligopoly;
Law
- September 2022
- Article
Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities
By: Leemore Dafny, Christopher Ody and Teresa Rokos
The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations...
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- August 2022
- Case
Air Wars: Deregulating the U.S. Airline Industry
By: Tom Nicholas and James Weber
In the early decades of the twentieth century, the U.S. government assisted in the development of an airline industry by subsidizing the delivery of mail and allowing mail carriers to also fly passengers. Because the government awarded mail routes to the lowest...
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Keywords:
Government Regulation;
Deregulation;
Change Management;
Economics;
Entrepreneurship;
Financial Management;
Business History;
Human Resources;
Compensation and Benefits;
Labor;
Labor Unions;
Leading Change;
Leadership Style;
Crisis Management;
Industry Structures;
Operations;
Strategy;
Adaptation;
Competition;
Air Transportation;
Air Transportation Industry;
United States