Category Archives: Risk Management

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 genetic. ┬áPersonalized medicine involves … Continue reading

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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 read one all the way through, … Continue reading

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Breakthrough 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 experience breakthrough pain who have developed a level … Continue reading

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Obama Administration Shifts Agency Gears on Safety – What Does it Mean for Food and What Does it Mean for Drugs

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 as Acting … Continue reading

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FDA 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 (REMS), which the agency now has the … Continue reading

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