U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments. The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the…
FDA Reconsiders Training Requirements For Painkillers
WASHINGTON (AP) — The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents. The review comes as regulators disclosed that the number of doctors who completed voluntary training programs is less than half that targeted by the agency. A…
FDA: Scope Manufacturer Waited Years to Report Problems
Federal regulators have uncovered new violations by the manufacturer of medical scopes recently linked to outbreaks of deadly “superbug” bacteria at U.S. hospitals. Olympus Corp. failed to alert regulators to a cluster of 16 infections in patients who underwent procedures with the company’s scope in 2012, according to a warning letter posted online Monday by…
23andMe CEO Navigates Health Regulation
No Silicon Valley company better embodies the promise and the pitfalls of working in health care than DNA testing firm 23andMe. Launched in 2006 to a flurry of media coverage, the Mountain View, California-based company seemed to have every strategic advantage: millions in startup cash, celebrity endorsements, and a chief executive married to one of…