Limits Of Risk Management Practices Shown In Renewed Duragesic Warnings
FDA's approach to continued reports of deaths from fentanyl patches illustrates the challenges that the agency will face in managing drug risks even as it wields the new powers granted by the FDA Amendments Act
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One of FDA's mantras has been that is does not regulate the practice of medicine, and while the agency remains committed to that doctrine, it is now trying to find ways to better influence how doctors prescribe and discuss drugs through its "Safe Use" initiative
Creation of a risk management plan for Johnson & Johnson's Duragesic and generics could be the next regulatory step for the product after FDA's release of a Public Health Advisory on fentanyl overdoses
Drug manufacturers made a pledge to contribute $80 bil. in a mix of savings and revenue-raising initiatives to help fund health reform. In return, they could see a wide range of new business depending on how you look at the numbers.