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US Food and Drug Administration News

The FDA questions Xarelto safety due to defective device

The U.S. Food and Drug Administration is investigating on the reliability of the ROCKET-AF clinical trial that led to the approval of Xarelto. Despite the European Medicines Agency (EMA) confirming its validity, a defective device may have compromised it.

Will trans fat get banned in the U.S?

The Food and Drug Administration ruled Tuesday that artificial trans fat will be removed from the United States food supply within the next three years.

Drug company Eisai sues DEA to expedite drug ‘scheduling’

Approving medications is just one of the many tasks assigned to the Food and Drug Administration. They also regulate other items such as foods, additives, and medical devices.

U.S. FDA approves first bionic eye

The U.S. Food and Drug Administration has approved the first bionic eye. The implantable device was developed to help adults with limited vision from a rare genetic disorder to be able to see.

FDA's new Ambien and sleep drug recommendations

The FDA has announced the manufacturers of certain sleep drugs must lower the current recommended doses. The federal agency said that in the morning patients may be "high enough" to impair daily activities in the morning that require alertness.

FDA proposes new rules to fight food contamination

The U.S. Food and Drug Administration has proposed two new rules that are designed to improve food safety. The announcement was made on Friday by the agency and the rules are now open for review and public comment.

FDA delays generic Lipitor recall announcement 3 weeks

Ranbaxy Pharmaceutical's, a division of Ranbaxy Inc, issued a voluntary recall of atorvastatin, a generic form of the cholesterol lowering drug Lipitor.

Hershey warned by FDA over chocolate syrup labeling

The U.S. Food and Drug Administration (FDA) has told Hershey Co. claims about its chocolate syrups violate federal law. The warning was issued Feb. 14, however details weren't made public until yesterday.

FDA asks U.S. Marshals to seize ultrasound gel, bacteria found

Newark - U.S. Marshals have been asked to seize an ultrasound product from a N.J.-based company by the U.S. Food & Drug Administration after the agency found bacteria-contaminated samples.

Food and Drug Administration recent recalls

The US Food and Drug Administration issued four product recalls between March 29, 2012 and March 31, 2012. Products recalled can be found nationwide.

McDonald's says 'pink slime' no longer used in burgers

McDonald's has announced the fast food chain will no longer be using ammonia treated beef in its hamburgers. A controversial ingredient, the meat in question is inferior trimmings prone to contamination and treated with ammonium hydroxide.

FDA bans class of antibiotics for use in food producing animals

Washington - This week the U.S. Food and Drug Administration (FDA) announced a ban in using a particular class of antibiotics on food producing animals in order to preserve its effectiveness for treatments of illness in humans.

FDA unveils nine new graphic cigarette labels required in 2012

Washington - The FDA has unveiled nine new graphic warning labels that must appear on all cigarette packaging and advertising in the US beginning in the fall of 2012, in the most dramatic change to cigarette packs since the Surgeon General's warning was added in 1965.

Lazy Cakes melatonin-laced brownie stirs controversy

Memphis - A popular new relaxation brownie that contains melatonin and other naturally found herbal ingredients has hit store shelves, and is being touted by some as a legal alternative to marijuana brownies.

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