This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.
Results from a clinical trial of more than 250 participants with progressive multiple sclerosis (MS) revealed that ibudilast was better than a placebo in slowing down brain shrinkage. The study also showed that the main side effects of ibudilast were gastrointestinal and headaches. The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, and published in the New England Journal of Medicine.
Reflecting its uncompromising commitment to patient safety, Alcon announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market.
A new study showed that a change in the type of breathing tube paramedics use to resuscitate patients with sudden cardiac arrest can significantly improve the odds of survival and save thousands of lives. More than 90 percent of Americans who experience sudden cardiac arrest die before, or soon after, reaching a hospital.
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