Bristol-Myers Squibb agrees to pay the U.S. Government and participating states a total of $75 million to resolve allegations that it knowingly underp...
Federal Register notice: FDA announces an Emergency Use Authorization revocation of NovaSterilis Nova2200 using the NovaClean decontamination process....
FDA grants Empirical Spine a breakthrough device designation for its LimiFlex Paraspinous Tension Band and its use in spinal surgery.
Federal Register notice: FDA corrects an 8/31/2016 amended final rule that listed inaccurate cross-references to FDAs drug establishment registration ...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Veryan Medicals Biomimics 3D Vascular Stent Sys...
Special Counsel Henry Kerner says he is troubled by the way FDA handled a whistleblower complaint involving inspections at biologic facilities.
FDA provides information for applying to participate in the Medical Device Innovation Consortium Accelerate Sustainable Capability pilot study.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Siga Technologies Tpoxx (tecovirimat monohydrat...