[ Price : $8.95]
FDA releases the form FDA-483 issued following a 2023 inspection at an Eisai drug manufacturing facility in Gifu, Japan.[ Price : $8.95]
FDA accepts for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3% for treating adults and adol...[ Price : $8.95]
FDA releases the form FDA-483 with five observations from a 2023 inspection at the Hugel drug substance and product manufacturing ...[ Price : $8.95]
FDA clears a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter.[ Price : $8.95]
FDA warns Wilmington, MA-based Azurity Pharmaceuticals it is manufacturing and marketing unapproved new drugs with CGMP violations...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Idorsia Pharmaceuticals Quv...[ Price : $8.95]
FDA issues two briefing documents to facilitate discussion by the Oncology Drugs Advisory Committee of the risk/benefit assessment...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of four NDAs from multiple sponsors because they repeatedly failed to file require...