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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Quality Metrics a Key Theme at ISPE Quality Week

Posted on 05. Jun, 2015 by .

This past week, I attended the ISPE Quality Week conference in Washington, DC, and “quality metrics” and “quality culture” were two key themes that resonated through many sessions. Given ISPE’s ongoing efforts to identify the right metrics, which included a pilot program in 2015 to gauge the time and effort that industry needed to collect [...]

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Drug Shortages a Continual Responsibility of the FDA

Posted on 01. Jun, 2015 by .

One of the responsibilities of the Food and Drug Administration (FDA), within its legal authority, is to address and prevent drug shortages. On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA).  Among other things, Title X of FDASIA directs the Food and Drug Administration (FDA) [...]

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Final Guidance Released by FDA for Reprocessing of Reusable Medical Devices

Posted on 20. May, 2015 by .

The U.S. Food and Drug Administration recently announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. This is especially needed given the recent outbreaks of a “super bug” in several California hospitals where a number of patients were infected with the antibiotic-resistant bacterium [...]

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ISO 13485 Changes: Documenting the Competency Management Program

Posted on 18. May, 2015 by .

Last week I attended the excellent MedCon event at Xavier University, and while every session was informative, I was really intrigued by the session where changes to ISO 13485 were shared. Speakers for the session were Kim Trautman from FDA, Scott Sardeson from 3M, and Bill Brodbeck from STERIS. They all reviewed the proposed changes [...]

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