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Latest From Drug Safety
US FDA’s approval of labeling supplements for the hypoactive sexual desire disorder drug followed Sprout’s appeal of a safety-related change order; boxed warning now states patients should wait at least two hours after drinking alcohol before taking flibanserin.
Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.
Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.
After a 14-year-old legal dispute, the European Medicines Agency has now repeated its safety review of high-strength estradiol creams for treating vaginal atrophy and says it stands by its original recommendation to place a limit on how long patients should use these products.
Pink Sheet Podcast: Makena's Accelerated Approval Questions, Woodcock On Biobetters, Singulair's Safety Issues
Pink Sheet reporters discuss the upcoming Makena advisory committee meeting, Janet Woodcock's recent comments on the biosimilar market, and options for new safety communications for Singulair.
How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.
Amazon, Microsoft, IBM among those helping build new operations and innovation centers for the US FDA's safety surveillance system.
A trial has begun in France to investigate the roles of the French firm Servier and the former drug regulator AFSSAPS in the Mediator scandal, where an amphetamine-like drug was kept on the market despite mounting evidence of its cardiac side-effects.
Joint panel of the Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee was split on whether the US FDA should add a black box warning to the label of Merck's now generic Singulair, which is currently labeled with a warning and precaution about a risk of psychiatric events.
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