Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public...
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
AdvaMed calls for updates to FDA and HHS informed consent guidances.
FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvies...
FDA warns Nashville, TN-based Pinnacle BioLabs that it is marketing and distributing a diagnostic test for an unapproved indication that also has Qual...
FDA warns Gelderland, Netherlands-based Future Diagnostics Solutions about Quality System and Medical Device Reporting violations in its manufacturing...
The Federal Trade Commission says it is expanding its challenges to junk drug patents with warnings to 10 companies about over 300 patent listings for...
FDA issues a safety alert on the rare risk of intrahepatic cholestasis of pregnancy associated with the use of thiopurines (azathioprine, 6-mercaptopu...
