FDA reviewers raised several concerns about a study comparing the safety and effectiveness of Stryker's OP-1 Putty -- a bone-growth product used in spinal surgery -- against a bone-fusion procedure. An FDA advisory panel is set to meet Tuesday to evaluate Stryker's application for expanded approval of the product.
Two Democratic lawmakers introduced legislation in the Texas Senate that would mandate insurance companies to cover routine medical care for clinical-trial participants with life-threatening diseases. Opponents of the bill argued that it would result in higher patient-care costs, but supporters said the proposal aims only for continued coverage and that it would likely benefit the state's bioscience industry.
Medtronic said it recalled its BioGlide Ventricular Snap Shunt Catheter designed for patients with hydrocephalus, or excessive cerebral fluid. The move, which was classified by the FDA as a Class I recall, covers devices sold in the U.S., Ireland and Australia. The company said there have been no cases of permanent serious injury or patient deaths associated with the device.
Dr. Joshua Sharfstein, President Barack Obama's appointee for principal deputy at the Food and Drug Administration, is set today to become the agency's acting commissioner. Sharfstein will run the agency while the Senate holds hearings to confirm Dr. Margaret Hamburg, a former health commissioner of New York City, as FDA chief.