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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Entrepreneurship Weekly Roundup: 2/17/17

Weekly Roundup is a McNair Center series compiling and summarizing the week’s most important Entrepreneurship and Innovation news. Here is what you need to know about entrepreneurship this week: The International Entrepreneur Rule: The US Startup Visa Ramee Saleh, Research Assistant, McNair Center for Entrepreneurship During the last days of the Obama Administration, the United States Citizenship and Immigration Services (USCIS) passed the International Entrepreneur Rule. The legisla...
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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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Entrepreneurship Weekly Roundup: 11/11/2016

Weekly Roundup is a McNair Center series compiling and summarizing the week's most important Innovation and Entrepreneurship news. Here is what you need to know about entrepreneurship this week: Small Businesses Can Expect Policy Changes Under Trump The Associated Press Entrepreneurs might expect policy shifts under a Trump presidency. Trump has released his plan for his first 100 days in office. However, much uncertainty over his policies and objectives remains. The battle over heal...
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Small Business and Overtime Regulation

Clocking in: Small Business and Overtime Regulation What is the New Overtime Regulation? On December 1, 2016, the Labor Department will officially institute new regulations on overtime eligibility for workers. Announced on May 17, the new rules require business owners to pay salary workers earning up to $47,476 a year time-and-a-half overtime pay when they work more than 40 hours during the week. This new regulation will be updated every three years to adjust for average pay in the United Stat...
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Big Problems for Small Practices

Big Problems for Small Practices: Examining the Effect of the Affordable Care Act on Entrepreneurship in the Healthcare Field The doctor-patient relationship is an important aspect of healthcare. Small physician practices, offices with no more than a couple doctors, have been the long-standing foundation of this relationship. Unfortunately, legislative changes disincentivize doctors from being small business owners. The Health Information Technology for Economic and Clinical Health Act (HITE...
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