FDA Tries To Rebuild Its Science Reputation, Plans New Projects
This article was originally published in The Gray Sheet
Executive Summary
FDA is embarking on a series of projects this year to address key scientific questions and, in the process, help rebuild the agency's suffering reputation
You may also be interested in...
Regulatory News In Brief
Pediatric device report: FDA submits its first annual 1report to Congress on pre-market approval statistics for pediatric-use devices, posted April 28. The 2007 FDA Amendments Act requires the agency to submit the reports as part of a government effort to encourage development of devices for young patients. During fiscal 2008, FDA approved 15 PMAs and panel-track supplements and two humanitarian-use devices that treat or diagnose conditions with pediatric subpopulations, including Abbott's Freestyle Navigator continuous glucose monitor and Thoratec's Heartmate II left ventricular assist system. Two devices were specifically labeled for use in pediatric patients in FY 2008
Regulatory News In Brief
Pediatric device report: FDA submits its first annual 1report to Congress on pre-market approval statistics for pediatric-use devices, posted April 28. The 2007 FDA Amendments Act requires the agency to submit the reports as part of a government effort to encourage development of devices for young patients. During fiscal 2008, FDA approved 15 PMAs and panel-track supplements and two humanitarian-use devices that treat or diagnose conditions with pediatric subpopulations, including Abbott's Freestyle Navigator continuous glucose monitor and Thoratec's Heartmate II left ventricular assist system. Two devices were specifically labeled for use in pediatric patients in FY 2008
People In Brief
Peer Portner: The pioneer of the first electrical left ventricular assist device died Feb. 9, from cancer. Peer Portner, a Ph.D. trained in nuclear physics, lead a multidisciplinary team at Stanford University in the 1970s to develop the Novacor LVAD, used in the first bridge-to-transplant procedure in 1984. Portner also founded Novacor Medical, which was acquired by Baxter Healthcare in 1988. WorldHeart acquired the Novacor technology in 2000 and continues to market, on a limited basis, an updated version of the product as a bridge-to-transplant pump, and, in Europe, as a longer-term destination therapy