This study describes withdrawals, boxed warnings, and safety communications affecting pharmaceuticals and biologics approved by the US Food and Drug Administration between 2001 and 2010, and associations between characteristics known at the time of approval and those events.
This Viewpoint from former US FDA Commissioner Robert Califf discusses existing agency decision support tools for assessing the benefits and risks of medical products under review and the advantages of harmonizing the currently separate frameworks used for evaluating devices and for drugs and biologics.
This Viewpoint discusses potential threats to public health that arise from provisions of the 2016 21st Century Cures Act that allow drug manufacturers to use surrogate measures of safety and that encourage the US Food and Drug Administration to emphasize speed over science in the drug approval process.
This Viewpoint discusses the Pediatric Research Equity Act, a 2003 law authorizing the US Food and Drug Administration to require the study of new therapies for pediatric populations, and proposes improvements to the law as it comes up for reauthorization in 2017.
This Medical News article discusses the progress and promise of the FDA’s Sentinel Initiative designed to surveille potential drug safety issues by mining claims data.
This Medical Letter review summarizes the safety of testosterone therapy for the improvement of sexual function, physical function, and vitality in older men with low serum testosterone levels and symptoms suggesting hypoandrogenism.
This Viewpoint discusses the role of the FDA’s Risk Evaluation and Mitigation Strategies program in monitoring drug safety and proposes ways the program can be redesigned for better integration into the US health care system.
This Viewpoint discusses the implications of evaluating novel agents in early, rather than advanced, disease states.
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