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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
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
- Supplement
Freelancer, Ltd. Case Supplement
By: Christopher Stanton, Karim R. Lakhani, Jin Hyun Paik and Nina Cohodes
Over the course of the 2010s, the rapid advancement of mobile technologies and the rise of online freelancing platforms seemed to portend a radical transformation of labor markets into on-demand, flexible talent pools. Even though several Fortune 500 companies,...
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Keywords:
Labor Markets;
Freelancers;
Change Management;
Corporate Entrepreneurship;
Globalized Firms and Management;
Human Capital;
Employment;
Digital Platforms;
Global Range;
Adoption;
Governing Rules, Regulations, and Reforms;
Growth and Development Strategy;
Computer Industry;
Electronics Industry;
Employment Industry;
Information Industry;
Australia;
United States;
Philippines
- 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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- November 2022
- Case
The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales
By: Regina E. Herzlinger and Tiffany Farrell
Can an online pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous technological innovation...
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- 2022
- Chapter
The Origins of the Developmental State: The European Experience
Book Abstract: There has been a major revival of interest in State Capitalism: what it is, where it is found, and why it is seemingly becoming more ubiquitous. As a concept, it has evolved from radical critiques of the Soviet Union, to being deployed by neo-liberals to...
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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 (Revised November 2022)
- Case
The Uyghur Forced Labor Prevention Act: Forced Labor and Genocide in U.S.-China Relations
By: Jeremy Friedman and David Lane
On June 21, 2022, the Uyghur Forced Labor Prevention Act (UFLPA) went into effect, requiring companies to prove that goods imported from the People’s Republic of China were not made with forced labor. The bill was a reaction to reports of products being made with...
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Keywords:
Ethics;
Multinational Firms and Management;
Globalized Markets and Industries;
Governing Rules, Regulations, and Reforms;
Policy;
Government Legislation;
International Relations;
Labor;
Wages;
Law Enforcement;
Law;
Rights;
Operations;
Supply Chain Management;
Business and Government Relations;
Agriculture and Agribusiness Industry;
Manufacturing Industry;
Mining Industry;
China;
United States
- 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
- August 2022
- Case
SuperRare: Turning an NFT Marketplace into a DAO
By: Jeffrey J. Bussgang, Scott Duke Kominers and Amy Klopfenstein
In June 2021, John Crain and Jonathan Perkins, the founders of SuperRare, a marketplace for non-fungible tokens (NFTs), contemplate whether to transform their company into a decentralized autonomous organization (DAO). Crain and Perkins founded SuperRare in 2018 to...
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Keywords:
NFTs;
Crypto Economy;
Alternative Assets;
DAOs;
Arts;
Governance;
Governance Controls;
Governing Rules, Regulations, and Reforms;
Information Technology;
Technology Adoption;
Internet and the Web;
Digital Platforms;
Innovation and Invention;
Technological Innovation;
Disruptive Innovation;
Finance;
Currency;
Investment;
Markets;
Auctions;
Bids and Bidding;
Demand and Consumers;
Network Effects;
Market Design;
Market Transactions;
Market Timing;
Web Services Industry;
North and Central America;
United States
- August 2022
- Article
The U.S. Approach to Antitrust Policy in Technology Markets
By: Shane Greenstein
This report illustrates the strengths and weaknesses of the U.S. approach to antitrust policy by drawing lessons from three cases: United States v. AT&T, United States v. Microsoft, and United States v. Google. The cases against AT&T and Microsoft are historical cases,...
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- 2022
- Working Paper
Calling All Issuers: The Market for Debt Monitoring
By: Huaizhi Chen, Lauren Cohen and Weiling Liu
A substantial fraction of local governments refinance their long-term debt with significant delays—resulting in sizable losses. Using data from 2001 to 2018, we estimate that U.S. municipals lost over $31 billion from this delayed refinancing, whereas the entire U.S....
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- 2022
- Working Paper
Consumer Reviews and Regulation: Evidence from NYC Restaurants: Evidence from NYC Restaurants
By: Chiara Farronato and Georgios Zervas
We investigate the informativeness of hygiene signals in online reviews, and their effect on consumer choice and restaurant hygiene. We first extract signals of hygiene from Yelp. Among all dimensions that regulators monitor through mandated restaurant inspections, we...
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- January 2022
- Background Note
Common Prosperity? China Shifts Left
By: William C. Kirby and Noah B. Truwit
Since the founding of the People’s Republic of China in 1949, the ruling Chinese Communist Party (CCP) has been mistrustful of entrepreneurs and the private sector that operates outside the government’s authority. In its first decades under Mao Zedong, the CCP...
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Keywords:
Market Reform;
Gdp;
Government Administration;
Government and Politics;
Private Sector;
Governing Rules, Regulations, and Reforms;
Economy;
Globalized Economies and Regions;
Entrepreneurship;
Business and Government Relations;
Globalized Markets and Industries;
Social Issues;
Society;
Economic Growth;
China
- January 2022
- Case
FIFA and The World Cup: The Future of Football
By: Anita Elberse, Oliver Band and Howard Johnson
Should FIFA host its biggest event—the FIFA World Cup—every two years instead of every four, as it has been doing since the event’s inception in the 1930s? In September 2021, Gianni Infantino, the president of the International Federation of Association Football...
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- 2021
- Working Paper
Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response
By: Alexander J. MacKay and Samuel 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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- 2021
- Working Paper
Who Benefits from Online Gig Economy Platforms?
By: Christopher Stanton and Catherine Thomas
This paper estimates the magnitude and distribution of surplus from the knowledge worker gig economy using data from an online labor market. Labor demand elasticities determine workers’ wages, and buyers’ past market experience shapes both their job posting frequency...
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- October 2021 (Revised November 2022)
- Case
The 2012 Spanish Labor Reform: Lifting All Boats, or Leveling Down?
By: Vincent Pons, Rafael Di Tella, Santiago Botella and Elena Corsi
Since 1978, Spain had struggled to control unemployment. The country’s labor law was protective of employees hired long-term and companies used temporary contracts as buffers. In 2012, amid economic recession and a 23.6% unemployment rate, a center-right government of...
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Keywords:
COVID-19 Pandemic;
Labor Market;
Unemployment;
Recession;
Globalized Markets and Industries;
Government Legislation;
International Relations;
Working Conditions;
Employment;
Labor Unions;
Contracts;
Social Issues;
Public Opinion;
Governing Rules, Regulations, and Reforms;
Spain;
European Union
- 2021
- Working Paper
The Business of K-12 Education in China
By: Geoffrey Jones and Yuhai Wu
This working paper examines the evolution of K-12 education in China, especially between 1985 and the present day, drawing extensive interviews with participants in the educational sector. China has been hugely successful in reaching almost 100 percent literacy,...
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