[ 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...[ Price : $8.95]
FDA Webview editor Jim Dickinson analyzes the evolving legacy of departing CDRH director Jeff Shuren and his hand-picked interim s...[ Price : $8.95]
A 2023 inspection at South Koreas C&T Dream Co. leads to a nine-observation FDA Form-483 that cites significant GMP deviations.[ Price : $8.95]
Gilead Sciences recalls one lot of Veklury (remdesivir) for injection 100 mg/vial, after it received a customer complaint about th...[ Price : $8.95]
FDA has appointed industry veteran and consultant Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing ...