FDA Issues Complete Response Letter For Iclaprim (Medical News Today)
Arpida Ltd. (SWX: ARPN) announces that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for intravenous iclaprim for the treatment of complicated skin and skin structure infections (cSSSI).

Government Accountability Office Report Finds Flaws In FDA's High-Risk Medical Device Approval Process (Medical News Today)
FDA continues to use a review and approval process created in May 1976 for high-risk medical devices that does not do enough to ensure that the products are safe and effective, according to a report released on Thursday by the Government Accountability Office, the AP/Denver Post reports.