FDA accepts for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3% for treating adults and adolescents ages 12 and ...
FDA releases the form FDA-483 with five observations from a 2023 inspection at the Hugel drug substance and product manufacturing facility in the Repu...
FDA clears a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter.
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...
FDA has appointed industry veteran and consultant Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing William Maisel who r...
