Medical Device Startups and the FDA

Does the FDA approval process impede innovation? Medical devices must be reviewed for safety and effectiveness by the Food and Drug Administration before being marketed in United States, which encompasses 43 percent of the global market for medical devices. Startups in the medical device industry are often dissatisfied with this approval process, favoring the FDA's European Union peer, CE Marking. Some founders even believe the time consuming and expensive FDA process "holds back the entire indu...
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The Carried Interest Debate

In the 2016 election, carried interest and its taxation was a hot topic. Often explained as a “loophole” that allows the rich to exploit tax codes, carried interest is not a political issue that clearly fits within party lines. Lobbying by the financial sector occurs on both sides of the political aisle, and there are opponents and supporters within both parties. What are the dynamics of this debate, and what are the arguments for whether carried interest should be taxed differently? Private In...
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Global Policy Uncertainty and U.S. Stock Trends

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The Financial Times has predicted that “the rise of Donald Trump may already be casting a shadow over the global economy.” When it comes to the Trump Administration, the world is unsure what policies to expect. Trump’s positions on international trade and tendency toward nationalist policies are a concern for the rest of the world. However, the U.S. stock market is performing at record-breaking highs. Economic research has linked policy uncertainty to stock market slowdowns. If this is so, wh...
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Congress Turns Its Attention to Entrepreneurship and Innovation—But Does It Take Effective Action?

Legislation passed during the first three months of  the 115th Congress pays disproportionate attention to entrepreneurship and innovation. McNair Center research shows that in a typical congressional session, less than 2 percent of legislation introduced is relevant to E&I issues. As of March 23, three of the ten bills that have become law during the 115th Congress directly address entrepreneurship and innovation. A focus on entrepreneurship and innovation issues does not alone make for ef...
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Crowdfunding

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What is crowdfunding? Crowdfunding is constantly evolving and hard to define. Elizabeth M. Gerber at Northwestern University defines crowdfunding as “an open call over the Internet for financial resources in the form of a monetary donation, sometimes in exchange for a future product, service or reward.” Due to the ease and availability of crowdfunding sites, crowdfunding has changed the way entrepreneurs source funds. A typical modern crowdfunding campaign begins with a page on a crowdfundin...
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The International Entrepreneur Rule: The US Startup Visa

The Obama administration proposed new provisions for immigrant entrepreneurs in August 2016. The administration designed the proposal to attract international entrepreneurial talent to the United States, especially in advanced technology fields. In mid-January, with only days left in President Obama’s term, the United States Citizenship and Immigration Services (USCIS) finalized the details of the "International Entrepreneur Rule." It is scheduled to go into effect on July 17, 2017. Whether it g...
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Reducing Recidivism through Entrepreneurship

Reducing Recidivism through Entrepreneurship High rates of recidivism in the United States negatively affect prisons, inmates, the government and tax-paying citizens. In 2013, the U.S. imprisoned 2,220,300 people. A Bureau of Justice Statistics study found that within three years of release, 67.8% of released prisoners were rearrested. Within five years, 76.6% of released prisoners were rearrested. Researchers typically link recidivism to unemployment, low levels of education, mental health ...
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Patents and the Cancer Moonshot

Patents and the Cancer Moonshot: How Subject Matter Eligibility Affects Research When standard cancer treatments fail, some doctors are turning to the developing field of immunotherapy. Immunotherapy involves treatments that use the patient’s own immune system to combat cancer. Both pharmaceutical companies and the federal government see the promise in funding research in this innovative field. However, R&D in cancer treatments is a time-intensive process, and it takes months, if not years,...
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The Right to Entrepreneurship

USAID has worked to increase micro credit accessibility. For example, this project in Indonesia provided loans to rural women. https://commons.wikimedia.org/wiki/File:USAID_Micro_Credit_Project.jpg
Entrepreneurship and human rights are not frequently mentioned in the same conversation in the United States. However, in international policy, human rights and entrepreneurship are linked by many common policy goals, including enforcing the rule of law, improving infrastructure and fighting corruption. Rights necessary to pursue entrepreneurial endeavors–like the right to participate in the economy, the rights to education and information and access to credit–are considered crucial for the worl...
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True Impact of the Bayh-Dole Act

Addressing the True Impact of the Bayh-Dole Act Since the passage of the Bayh-Dole Act in 1980, many researchers have debated its contribution to the transfer of technology from universities to industry. Some credit the act as an engine of economic growth responsible for the emergence of the biotechnology industry. Critics say that the law decreased data sharing and basic research and increased health care costs. Others think that the act had little impact and that changes in university patenti...
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