Federal Register notice: FDA makes available a final guidance entitled Enrichment Strategies for Clinical Trials to Support Demonstration of Effective...
Federal Register notice: FDA makes available a final guidance entitled Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical De...
Federal Register notice: FDA makes available a draft guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and A...
Federal Register notice: FDA makes available a final guidance on Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro...
FDA Webview editor Jim Dickinson sees a troubling parallel between the influence Boeing has had at FAA and the same post-Reagan influence that industr...
FDA plans an advisory committee meeting to discuss nitinol and other metals in device implants to understand the potential risk for certain patients t...
An updated FDA safety alert on paclitaxel-coated products says that a preliminary data review has identified a potentially concerning signal of increa...
FDA clears a Thornhill Research de novo marketing request for the ClearMate, intended to be used in an emergency room setting to help treat patients s...