Orthovita has received FDA approval to operate a production plant in Malvern, Pa., that will manufacture collagen used in its Vitagel surgical hemostat device designed to control hemorrhage during surgeries. The company said the facility also will allow it to develop and commercialize additional collagen-based products.
FDA Commissioner Dr. Andrew von Eschenbach named CMS chief of operations John Dyer to be the FDA deputy commissioner for operations and chief operations officer. Von Eschenbach also named the FDA's deputy commissioner for operations Dr. Janet Woodcock as the agency's first chief medical officer. Dyer will seek to strengthen the management, business processes and information technology at FDA, and Woodcock will oversee scientific and planning operations.
President George W. Bush is expected to propose in tonight's State of the Union address a plan to shift some Medicare and Medicaid funds to states so they can ensure residents access to affordable health insurance. Bush plans to propose two health care initiatives, including the Affordable Choices Initiative, but congressional Democrats were quick to say they probably would not be adopted.
Medtronic's Physio-Control unit has told its employees it is considering layoffs, a week after the Redmond, Wash., plant suspended shipments of its defibrillators and other products. Medtronic says it still plans to spin off the company when business resumes, and a spokesman said, "We're working very quickly to try to resolve" the problem.
Experts from three leading universities have established criteria that will aid researchers in disclosing financial ties in their work. "There is near-universal agreement about the need for clinical researchers to disclose financial interests to research participants, but until now there has been little guidance available on exactly how to do it," said the lead investigator.