FDA Grants Fast Track Designation to Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer ...
OSLO, Norway, August 23, 2011 /PRNewswire/ Algeta ASA , a company focused on the development of novel targeted cancer therapeutics, today announced that radium-223 chloride has been granted Fast Track designation by the U.S. Food and Drug

Report Urges FDA to Scrap 510(K) Medical Device Approvals
A medical watchdog has called for the elimination of the system the U.S. Food & Drug Administration (FDA) uses to approve most medical devices. According to a panel from the Institute of Medicine, that streamlined process, known as 510(k) approval, offers patients no assurance of safety. As we ve reported in the past, 510(k) approvals are [...]