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Bristol-Myers Squibb has significantly strengthened its bleeding risk warning for patients on its blood-thinner Coumadin by adding a “black box” warning to the product’s label, according to revised labeling posted on the FDA website.
Regulators and devicemakers pledged to implement many of the Heart Rhythm Society (HRS) recommendations released Sept. 28 that ask the FDA, industry and physicians to do a better job of tracking heart device malfunctions and communicating device adverse event information.
One of the largest drug-eluting stent makers, Boston Scientific, is looking at the way it designs these devices after new clinical trial analyses linked them to an increased risk of blood clots.
Authors of a new report say it exonerates Merck from allegations that the company knowingly kept its painkiller Vioxx on the market despite underlying cardiovascular risks, but investigators also condemn Merck’s “poor judgment and errors,” including public statements that downplayed the health hazards.
Authors of a new report say it exonerates Merck from allegations that the company knowingly kept its painkiller Vioxx on the market despite underlying cardiovascular risks, but investigators also condemn Merck’s “poor judgment and errors,” including public statements that downplayed the health hazards,
A trade group’s failure to make good on a commitment to the FDA has, in part, resulted in a decision by the agency to remove OTC status for all skin-bleaching creams because some contain a chemical that may cause cancer, according to the FDA.
Mylan Technologies wants the FDA to hold off on approving pain patches until studies show that overlays to keep the devices stuck to the skin are safe.
Preliminary study data on Merck’s experimental painkiller Arcoxia show it presents thrombotic cardiovascular risks similar to a commonly used anti-inflammatory drug, but other findings suggest that more work needs to be done before Arcoxia is finally approved for the U.S. market.
Roche’s acne drug Accutane, already known to cause birth defects, may raise the risk for patients to develop other health problems, according to a study published in the August issue of Archives of Dermatology.
Device firms can save a lot of money and trouble by using an engineering technique to identify product risks during the design phase, experts said in an Aug. 16 FDAnews audioconference titled "Medical Device Failure Analysis During the Design Process."