Congressional talks to renew the fees drugmakers pay to fund Food and Drug Administration reviews include proposals to fast-track evaluations of medicines for conditions with no approved cures, according to two U.S. Senate aides.
Makers of vaginally implanted surgical meshes, led by Johnson & Johnson, may have to conduct studies of three years or more on the products if the Food and Drug Administration follows an advisory panel’s lead.
The U.S. Food and Drug Administration asked Johnson & Johnson , which is already facing more than 1,000 lawsuits over hip replacements, to study whether its implants raise the level of metal in patients’ blood to dangerous levels.
Roche Holding AG’s failure to persuade a U.S. panel to back Avastin in breast cancer is the third such loss for the Swiss drugmaker as it looks for new ways to expand sales of the world’s top-selling cancer medicine.
Women are often underrepresented in studies used to win U.S. approval for medical devices in contradiction of government requirements, a report today in the American Heart Association’s journal Circulation showed.
The Food and Drug Administration’s top medical-device regulator said the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits.
Arena Pharmaceuticals Inc. fell 12 percent in New York trading after the company said it would reapply for clearance of lorcaserin, the weight-loss drug that failed to win a U.S. advisory panel’s recommendation.