Federal Register notice: FDA announces an 8/22 public workshop entitled Development of Non-Traditional Therapies for Bacterial Infections.
FDA releases a guidance to help small businesses meet their antimicrobial animal drug sales reporting requirement.
Federal Register notice: FDA seeks comments on an information collection extension for Biosimilars User Fee Program.
Federal Register notice: FDA announces a 9/12 public hearing to solicit comments on its Predictive Toxicology Roadmap.
FDA releases a 32-page FDA-483 with 13 observations from an inspection at the firms finished drug manufacturing facility in Morgantown, WV.
FDA clears a Renovis Surgical Technologies 510(k) for the Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System.
FDA clears an Embolx 510(k) for its next generation Sniper Balloon Occlusion Microcatheter, intended for use for pressure-directed arterial embolizati...
CDERs Office of Prescription Drug Promotion says a Pfizer consumer video on its Estring fails to provide any risk information, creating a false and mi...