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...
Spectrum Pharmaceuticals withdraws a BLA for Rolontis (eflapegrastim), a treatment for chemotherapy-induced neutropenia in patients undergoing myelosu...
FDA releases a draft guidance expanding with questions and answers on an earlier guidance on a risk-based approach to clinical trial monitoring.
FDA publishes a guidance to help drug trial sponsors develop enrichment strategies that can be used to demonstrate drug and biological product effecti...