The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs. The agency said its inspectors targeted 31 compounding …
The U.S. Food and Drug Administration kicked off a series of public meetings on Thursday to explain its proposed new rules for improving the safety of the nation’s food supply – and gain feedback on the potential regulations. The rules …
The Food and Drug Administration said Wednesday that tool recalled by St. Jude Medical Inc. used to insert heart implants could potentially cause serious injury or death if used in patients. The company’s Amplatzer TorqVue delivery system is used to …
U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing foodborne illnesses that kill or sicken thousands of Americans annually. The new rules, required by the Food Safety Modernization …
The top U.S. drug regulator on Wednesday urged state officials to help close regulatory loopholes involving the safety of compounded drugs, such as the tainted steroid injections at the center of a deadly fungal meningitis outbreak. At a day-long meeting …
The U.S. meningitis outbreak that has so far killed 15 people and sickened more than 200 others is “nowhere near the end,” a top medical expert said Tuesday, a day after federal authorities warned more tainted drugs may be linked …
The deadly meningitis outbreak linked to contaminated pain injections has prompted calls for tighter federal regulation of compounding pharmacies, which have periodically been blamed for crippling and sometimes fatal injuries. But this isn’t the first time Congress has pushed for …
The U.S. Food and Drug Administration said it is having difficulty implementing expansive new rules to improve food safety, nearly two years after President Barack Obama signed the standards into law, because of a lack of funding. FDA chief Margaret …
Medical devices like hip implants and heart defibrillators will soon join the ranks of cars and toasters. The U.S. Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code …
President Obama is expected to sign into law a mammoth bill passed by Congress Tuesday that reshapes how the Food and Drug Administration assures the safety of the drug supply, particularly imported medicines. The bill is a must-pass piece of …