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. Personalized medicine involves … Continue reading
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
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
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
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
