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 amends its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete o...
Federal Register notice: FDA announces a 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Provention Bio BLA for eplizu...
Federal Register notice: FDA announces a 5/26-27 workshop entitled FDA Science Forum 2021.
Federal Register notice: FDA amends its electronic import entries regulation to correct the statutory citation in the sections of that regulation requ...
CDRH director Jeffrey Shuren describes the Centers Medical Device Development Tools program and Catalog of Regulatory Science Tools.