FDA Review posts the Federal Register notices for the week ending 6/8/2018.
FDA approves an AbbVies Venclexta (venetoclax tablets) in combination with rituximab for treating patients with chronic lymphocytic leukemia or small ...
FDA clears an Edap TMS 510(k) for its Focal One device for ablating prostate tissue.
Federal Register notice: FDA corrects a 5/15 proposed rule to amend its regulations concerning the classification of products as biological products, ...
Federal Register notice: FDA announces a 6/27 public workshop entitled Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic F...
Federal Register notice: FDA classifies the in vivo cured intramedullary fixation rod into Class 2 (special controls).
Federal Register notice: FDA announces the renewal of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years.
Federal Register notice: FDA submits a proposed extension for a collection of information on Medical Device Reporting: Electronic Submission Requireme...