Rebuilding Trust in the Life Sciences Industry

Posted on 16. Mar, 2015 by .

Many people reading this blog work in the Life Sciences field which, by definition, includes an understanding of science and the positive aspects that can come from science. This is why the anti-vaccine movement should serve as a warning to those of us who work in this industry. The trend away from proven, safe approaches [...]

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Skills Development Becoming Part of the Training and Qualification Process

Posted on 04. Mar, 2015 by .

Over the past year, the UL EduNeering Advisory Services team helped clients build a measurable and continuous On-the-Job Training and mentoring program that included documented assessments and mentoring programs. In a recent project, we helped a client build an “inventory” of role-based technical skills, focused on topics such as “Good Laboratory Practices” and “Proper Equipment [...]

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Interesting FDA Happenings

Posted on 02. Mar, 2015 by .

Here is a small list of recent FDA highlights: On January 1, 2015, the pilot for the Medical Device Single Audit Program (MDSAP) reached a major milestone – manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. were invited to participate in the program. Under this pilot, audits [...]

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What are Companion Diagnostics?

Posted on 19. Feb, 2015 by .

With the advent of personalized medicine, a key factor in ensuring the right medicine is available for the patient is companion diagnostics. Companion diagnostics are medical devices that help doctors decide which treatments to offer patients and which dosage to give, tailored specifically to the patient. According to the FDA, a companion diagnostic device can [...]

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The New England Patriots Have a Compliance Issue

Posted on 13. Feb, 2015 by .

If you are any kind of sports fan, a person who occasionally listens to network news, checks cnn.com or in any other way are paying attention to the world around you then you know the biggest issue recently in the world of sports is Deflate-Gate. For those of you who may not know, the New [...]

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FDA Moving from Mini-Sentinel to Sentinel

Posted on 13. Feb, 2015 by .

In May 2008, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the launch of FDA’s Sentinel Initiative, a long-term program designed to build and implement a national electronic system for monitoring the safety of FDA-approved drugs and other medical products.  So in 2009, the FDA [...]

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What are Biosimilars?

Posted on 06. Feb, 2015 by .

One growing area of the life science field is the creation and use of biosimilars. A biosimilar exists when there are no clinically meaningful differences between a biological product and its reference product in terms of the safety, purity and potency of the product. A simplistic definition of a biologic is that it is a [...]

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Helpful Calorie Counting

Posted on 04. Feb, 2015 by .

Would knowing how many calories are in that restaurant’s signature dish deter you from ordering it? Would the listing of the 2,785 calories that come with your dessert serve as a warning against ordering it? The FDA is banking on the hope that full knowledge of the calorie count on a restaurant’s menu will at [...]

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