Advice on managing "immune reconstitution inflammatory syndrome," a potentially dangerous over-activity of the immune system which can occur as formerly impaired immune responses rebound under treatment.
The proposed rule for medical devices does not apply to reports submitted on a voluntary basis.
Speaking during a telebriefing, Dr. Anne Schuchat, of the U.S. Centers for Disease Control and Prevention, said women at any stage of pregnancy should get the shot, the Associated Press reported.
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* a small lump or rash in the excision scar, on or under the skin
Lung function, as measured by FEV1 (how much volume can be exhaled in one second), was the primary or co-primary endpoint in all four studies.
The proposed regulation for medical devices would require manufacturers, importers and user facilities to submit reports to the FDA in electronic format, which will be loaded into the MAUDE database.
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Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
Women who are pregnant and new parents should get the swine flu vaccine when it becomes available this fall, to protect themselves and their children, U.S. health officials said Thursday.
We clearly need new options for patients with COPD and the results of these studies, published in The Lancet, confirm that roflumilast is beneficial.
Compared with placebo, roflumilast significantly reduced the rate of exacerbations and improved lung function in treated patients.
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Dialysis patients whose blood was not monitored for warfarin levels after they received the drug had the highest risk of stroke (almost three-fold higher than patients not on warfarin).