FDA issues a safety alert warning patients and health care professionals about risks associated with using unapproved or unauthorized devices for diab...
Federal Register notice: FDA seeks comments on an information collection extension for Applications for Food and Drug Administration Approval to Marke...
FDA clears a Flat Medical 510(k) for its EpiFaith syringe to deliver safe epidural locating solution.
Federal Register notice: FDA corrects a 4/12 Federal Register notice on the classification of medical device accessories distinct from other devices, ...
AbbVie halts a Phase 3 study called INTELLANCE-1 that was evaluating depatuxizumab mafodotin in patients with newly diagnosed glioblastoma based on da...
FDA says it inspected 26% (739) of the 2,852 foreign-based human drug manufacturing sites outside of the U.S. in fiscal year 2018.
FDA approves a Takeda Pharmaceuticals supplemental NDA to expand Gattexs (teduglutide) for injection to pediatric patients aged one year and older wit...
FDA clears a GenePOC 510(k) for the Carba assay and its use with the Revogene device to detect carbapenem-producing organisms.