Alvogen recalls two lots of fentanyl transdermal system 12 mcg/h transdermal patches due to a labeling error.
FDA announces that the National Academies of Science, Engineering, and Medicine (NASEM) is conducting a study to examine the clinical utility of treat...
FDA accepts a Molecular Templates IND application for MT-5111, an engineered toxin body targeting HER2-positive solid tumors.
FDA Review posts the Federal Register notices for the week ending 4/19/2019.
FDA Review posts product approval summaries for the week ending 4/19.
Federal Register notice: FDA makes available a draft guidance entitled Technical Performance Assessment of Quantitative Imaging in Premarket Device Su...
Federal Register notice: FDA announces the availability of a draft guidance entitled Technical Considerations for Non-Clinical Assessment of Medical D...
Federal Register notice: FDA makes available a draft guidance entitled Bispecific Antibody Development Programs.