FDA clears a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter.
Federal Register notice: FDA makes available three draft guidances for its Accreditation Scheme for Conformity Assessment Program.
Federal Register notice: FDA makes available a draft guidance entitled Chemical Analysis for Biocompatibility Assessment of Medical Devices.
FDA approves UCBs Bimzelx (bimekizumab-bkzx) for treating adults with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with...
Federal Register notice: FDA withdraws approval of four NDAs from multiple sponsors because they repeatedly failed to file required annual reports.
FDA Webview editor Jim Dickinson analyzes the evolving legacy of departing CDRH director Jeff Shuren and his hand-picked interim successor Michelle Ta...
A 2023 inspection at South Koreas C&T Dream Co. leads to a nine-observation FDA Form-483 that cites significant GMP deviations.
Gilead Sciences recalls one lot of Veklury (remdesivir) for injection 100 mg/vial, after it received a customer complaint about the presence of a glas...
