Economic Considerations For REMS

The Food and Drug Administration Amendments Act of 2007 (FDAAA) establishes broader authority for the agency in a variety of ways, perhaps none more game-changing than the authority to require a Risk Evaluation and Mitigation Strategy (REMS) for new and […]

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FDA to Require REMS of Opioid-Based Drugs

Citing authority granted to the agency by the FDA Amendments Act of 2007 (FDAAA), FDA sent letters in early February to manufacturers of opioid painkillers, including Ortho McNeil Janssen, Purdue Pharma, Roxanne, King Pharma, Actavis, Xanodyne, Endo, Lavipharm Labs, Mylan […]

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