Federal regulators are working on a stronger label for a widely used diabetes drug, Byetta, after deaths continue to be reported despite earlier government warnings.
Federal regulators are working on a stronger label for a widely used diabetes drug, Byetta, after deaths continue to be reported despite earlier government warnings.
WASHINGTON — Despite safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday.
Schering-Plough said regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by analysts.
Schering-Plough said regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by analysts.
Japan has lifted a ban on imports of North American lobster that had been linked to a misunderstanding over safety.
The Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs in a way that could further restrict their use in treating patients with cancer.
Industry leaders are questioning whether the weak produce-tracking rules that many of them once championed are more a curse than a blessing, several food safety experts say.
The move, which the F.D.A. is expected to announce on Wednesday, represents the first time the agency has ordered changes in a drug’s prescribing information.
The agency said patients with a variation in an immune system gene should not be given the drug abacavir because they are at a far higher risk of a severe allergic reaction.
Drug makers whose products are not ready for approval in the U.S. will soon get the word from regulators in a new format intended partly to avoid scaring investors.