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...
Sen Susan Collins and a bipartisan group of her colleagues introduce the Creating Hope Reauthorization Act to extend until 2030 the FDA priority revie...
A University of Illinois Chicago College of Pharmacy petition calls on FDA to authorize a new form of monograph for biological products.
3D Communications shares the results from its survey of FDA advisory committee members on committee reform issues.
