Navigating the Quality Assurance and Regulatory Landscape in Compounding Pharmacy
May 10, 2017
By Washington M. Osiro

Contributors Author: Washington Osiro, M.B.A (cand.) Reviewers: Devin McElroy, Ph.D. (cand.), CSSGB, CQA Sormeh Mahjouri, MPH Introduction This article provides an overview of the compounding pharmacy industry given reports of adverse events[1], some resulting in patient deaths, that has befallen it. The summary is designed to provide compounding pharmacy management a brief history and state-of-the-industry overview. Between understanding the industry’s history and its current state, management will be better-positioned to formulate a strategy on how to navigate the quality assurance and regulatory landscape in the process assure patient safety by

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Theranos: What We Should Learn
December 13, 2016
By Sormeh Mahjouri

I remember first hearing about Elizabeth Holmes and Theranos in 2013 when I was still working for a medical device company in Minnesota, and I found myself quite captivated by the story: A young woman and former Stanford undergraduate who dropped out of college to develop minimally-invasive technology for the collection and analysis of blood. She wanted to transform personalized medicine through a prick of blood that would yield hundreds of lab tests—how could I not be fascinated with such a story? It seemed too good to be true, and

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The Impact of Brexit on the U.S. Medical Device Industry
October 14, 2016
By Devin McElroy

There are a few anxieties by U.S. medical device manufacturers concerning the projected exit of Great Britain from the European Union. 1. Does GB allow the U.S. to import devices bearing the CE-Mark? 2. Do Member states within the EU allow imported medical devices having a British Notified Body such as BSI & SGS? 3. Does the British Health care system include reimbursement changes? 4. Does GB generally allow the import of any product from any foreign country? Let’s focus on these concerns. The CE-Mark is global, with the exception

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