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...
A new FDA report outlines the agencys current workforce needs as mandated by the 21st Century Cures Act.
Stakeholders suggest generic drug regulatory science research topics for FY 2019.
FDA accepts for priority review a Jazz Pharmaceuticals supplemental NDA seeking revised labeling for Xyrem (sodium oxybate) oral solution, to include ...