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A recent study shows that angioplasty using stents -- also known as percutaneous coronary intervention (PCI) -- may offer no significant benefit compared with standard drug therapy in treating some heart attack patients.
After cataloging shortcomings in its adverse event review process for devices and combination products, Medtronic said it decided to establish a centralized review group to develop a more efficient reporting system.
The use of high doses of epoetin to treat anemia in patients with chronic kidney disease raises the risk for cardiovascular events, results from a new study cautioned.
In an attempt to improve the quality and effectiveness of adverse event reporting, Health Canada issued a draft guidance Oct. 30 describing the procedures manufacturers should follow when unintended drug reactions occur.
The results of a recent clinical trial published in the Oct. 11 issue of the Journal of the American Medical Association (JAMA) appear to support previous findings that device treatments may be less risky than clot-busting drugs for some heart-attack patients.
After cataloging an array of shortcomings in its adverse event review process for medical devices and combination products, Medtronic decided to establish a centralized review group to develop a more efficient adverse event reporting system.
Forty-three women have filed suit against Ortho-McNeil Pharmaceutical and McKesson alleging the companies misrepresented the known risks associated with the use of Ortho Evra, a birth control skin patch.
A recent independent study partially funded by Smith & Nephew "showed that detectable levels of proteins and nucleic acids were present in reprocessed single-use only arthroscopic shaver blades," the firm's endoscopy division said Oct. 19.
Israel’s Ministry of Health and sanofi-aventis said that the company’s flu vaccine had no connection to the recent deaths of four people in Israel who had received the shots, according to Israeli radio reports.
Bayer suspended two people involved in a failure to disclose study results to the FDA that showed Trasylol could cause serious side effects, the company announced Oct. 13.