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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FDA and Biosimilars: Some Guidance Documents

Posted on 29. Jun, 2015 by .

A biosimilar is a product that is highly similar to, and has no clinically meaningful differences from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs. In March, the FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), used to help stimulate growth [...]

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FDA Enforcement & Business

Free Speech vs. the FDA

Posted on 25. Jun, 2015 by .

In an interesting case, Amarin Pharmaceuticals based in Dublin, Ireland is asking a New York federal court to declare its off-label promotion of a cholesterol-lowering drug constitutionally protected free speech. This case has arisen after several FDA rejections of Amarin’s request to promote the drug for a wider patient population. Amarin has been arguing that [...]

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How to Best Leverage Compliance Learning Experts

Posted on 22. Jun, 2015 by .

How do we become experts in something? We study … We train … We apply … We reflect … We improve … Then we rinse and repeat over and over again in a particular or variety of areas, disciplines, fields or topics. Now that I’m part of UL Advisory Services, which is a team of [...]

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Medical Device Reporting Requirements

Posted on 17. Jun, 2015 by .

Medical devices are life-saving pieces of equipment that allow many patients to have a quality of life they would not otherwise be able to experience. Officially, according to the FDA, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or [...]

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HR Ramps Up Efforts to Close the Skills Training Gap

Posted on 08. Jun, 2015 by .

The move from compliance to competency is becoming mandatory for Life Science companies operating globally in the face of aggressive competition, regulatory oversight, financial pressure, and a shrinking talent pool. This challenges Human Resources managers to hire, train, and retain top talent with desirable technical skills and competencies, while making sure those employees perform up [...]

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