Topic: Food and Drug Administration
Federal health advisers said Thursday an electronic heart implant should be approved for a large group of heart-disease patients who currently aren't eligible for the device. A Food and Drug Administration panel of cardiologists voted unanimously in favor of Boston Scientific's heart-regulating device to treat ...
COLLEGE PARK, Maryland (Reuters) - A U.S. advisory panel on Thursday unanimously recommended approval of implanted cardiac devices made by Boston Scientific for patients with earlier stages of heart failure. The Food and Drug Administration panel urged clearance of Cardiac Resynchronization Therapy Defibrillators, or CRT-Ds, for patients with heart failure who have no symptoms or only mild symptoms. Panel members ...
WASHINGTON (Reuters) - U.S. health officials on Thursday sought to clamp down on the marketing of cigarettes to children and teenagers, issuing national limits on vending machine sales, free samples and taking other steps after a failed attempt more than a decade ago. Under the U.S. Food and Drug Administration rules, tobacco companies such as Reynolds American Inc and ...
WASHINGTON (Reuters) - Novartis AG and Astellas Pharma eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in children, U.S. Food and Drug Administration staff said in documents released on Thursday. Agency scientists said 46 cancer cases and 71 infection cases have been reported in patients aged 16 and younger from ...
