When to Move from the QMS Training Module to the LMS

Posted on 20. Aug, 2015 by .

It’s really helpful for UL to talk to a wide range of QA executives about their software technology goals. Many QA managers tell us that they have to start with the Quality Management System (QMS), which certainly makes sense.  QMS applications enable the QA team to record and track quality issues in the manufacturing and [...]

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FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs

Posted on 17. Aug, 2015 by .

Next time you want to relieve that minor ache or pain after your marathon or half-marathon or even from just sleeping on your arm in a strange way, think twice. The FDA recently strengthened an existing warning. The warning on prescription drug labels and over-the-counter (OTC) Drug Facts labels is designed to indicate that nonsteroidal [...]

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Searching Through New FDA Guidance Documents

Posted on 10. Aug, 2015 by .

Often, it can be difficult to try to wade through all the new information and guidance being issued by the Food and Drug Administration (FDA). It seems like there is a constant (and never ending) stream of new guidance and draft documents. Fortunately, there is a simple way to find what you are looking for. [...]

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What to Do with your Refrigerated/Frozen Products if the Power Goes Out

Posted on 03. Aug, 2015 by .

Summer time is filled with fun and sun but, increasingly, it also seems to be filled with severe weather phenomenon such as floods, heat waves and power outages. Here are some FDA instructions that may assist interested persons in determining what to do with their biological products in the event of a power failure. You [...]

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CEOs and Presidents in Trouble (Again)

Posted on 27. Jul, 2015 by .

It seems that every time you turn around, a president of a company or CEO in the Life Sciences industry is being brought up on charges or a consent decree is being issued. Here are two such examples. Recently, the U.S. District Court of the District of New Jersey sentenced the OtisMed Corporation’s (OtisMed) former [...]

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Cost of Bringing a New Pharmaceutical to Market Pegged at About $2.6 Billion

Posted on 20. Jul, 2015 by .

A study by the Tufts Center for the Study of Drug Development  broke down the cost to bring a new prescription medicine to market at an estimated $2,558 million. The two factors making up that number are the actual average out-of-pocket cost of $1,395 million as well as the time costs (expected returns that investors [...]

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What is the 21st Century Cures Act?

Posted on 13. Jul, 2015 by .

On May 21, 2015, the committee on Energy and Commerce voted 51-0 to advance the 21st Century Cures Act, a bill to help modernize and personalize health care, encourage greater innovation, support research, and streamline the system. Here are some highlights of what the bill is about: Removing barriers to increased research collaboration—Experts agree that [...]

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Summertime Guidance from the FDA: Protecting Yourself from UV Rays

Posted on 06. Jul, 2015 by .

It is that time of year again; time to head to the beach. And as most people know, a trip to the beach typically ends up with some type of sunburn if you are not careful. Even on cloudy days. In fact, anytime you are outside in the summertime or any time, you need to [...]

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