The drug development consulting firm Rahaa asks FDA to require stability studies under refrigerated conditions for generic versions of prednisolone op...
Federal Register notice: FDA renews for two years its Peripheral and Central Nervous System Drugs advisory committee.
FDA approves a Galderma BLA for Nemluvio (nemolizumab), a pre-filled pen for subcutaneous injection for adults with prurigo nodularis.
FDA warns Lublin, Poland, physician Konrad Rejdak about Bioresearch Monitoring violations in a clinical study for which he was the study director.
FDA warns Jordans Nowrez and Ismail Shukri Company about CGMP violations in the production of OTC drugs.
FDA warns Globus Medical about Quality System and Medical Device Reporting violations in its production of the Excelsius GPS surgical robot.
A CDER Manual of Policies and Procedures lists responsibilities for the Office of Surveillance and Epidemiology and other CDER offices dealing with th...
Tandem Diabetes Care updates its March recall of its Apple iOS t:connect mobile app in the U.S. due to an issue that can cause rapid depletion of a us...
