Topic: Food and Drug Administration
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) - 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 ...
The Food and Drug Administration FDA has ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg ...
WASHINGTON (Reuters) - Congress will pass a new law to overhaul the antiquated U.S. food safety system by the end of the year, U.S. Rep. Rosa DeLauro, an influential House lawmaker, said on Wednesday. The first major reform of the system in 50 years could be followed by another close look at how meat and poultry are inspected, and ...
