Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturing changes to biosimi...
The U.S. House of Representatives passes the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rare diseases.
FDA releases the form FDA-483 issued following a 2023 inspection at an Eisai drug manufacturing facility in Gifu, Japan.
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...
