Risk Management Workshop
The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders. Risk Management has been an increasing source of...
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Risky Business
Last week, the FDA announced the formation of a new Risk Communications Advisory Committee that will differ from the existing Drug Safety and Risk Management Advisory Committee, presumably by focusing...
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Returning a Product to Market After it is Tossed
The FDA announced on Friday that the drug Zelnorm, manufactured by Novartis, would be returning to market for the treatment of women with irritable bowel syndrome (IBS) for certain patients only....
View ArticleFDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with...
This is not exactly under the headline of news – a Complete Response Letter (CRL) was issued to Cephalon on the 15th of September for its supplemental New Drug Application (sNDA) for FENTORA(R)...
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A Conversation with the FDA About the Nature of REMS
In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law by President Bush. The legislation contained a great deal of reform of FDA regulation over the pharmaceutical...
View ArticleFDA to Get More Specific on REMS and Painkillers
Yesterday, the FDA announced that it has sent letters to the manufacturers of both generic and brand name opioid based products that they may be required to have a Risk Evaluation Mitigation Strategy...
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Obama Administration Shifts Agency Gears on Safety – What Does it Mean for...
There have been a lot of changes at the FDA in the past few weeks – changes in personnel and changes in approach. Today the New York Times reports that Dr. Joshua Sharfstein, who has taken the reigns...
View ArticleBreakthrough in Pain Relief – Kind of….
No, it isn't a scientific breakthrough – it is a regulatory breakthrough. Yesterday the FDA approved a new opioid based pain relief medication indicated for use with patients in with cancer who...
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REMS – A Paper Tiger?
MedGuides are pieces of paper that are shoved into a bag with your prescription to warn a patient about possible side effects. I take some prescriptions myself that come with MedGuides. I never have...
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Personalized Risk Communication
Everyone has heard of the concept of personalized medicine – the idea that medicine can be steered to individuals who will be the most likely to benefit from it based on a number of factors, primarily...
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