Universal Meditech recalls (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they did not have FDA autho...
FDA commissioner Robert Califf easily manages criticisms of the agencys handling of the Covid-19 pandemic during a 2/8 House Energy and Commerce joint...
FDA warns the Palm Beach Fertility Center about significant repeat deviations from cellular and tissue regulations.
FDA warns Nendingen, Germany-based Getsch+Hiller Medizintechnik about Quality System violations in its production of adulterated and misbranded monopo...
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Administrative Practices and Procedures; Formal Hearin...
An FDA Office of Criminal Investigations probe leads to a Puerto Rico federal grand jury indictment against Magnetic Healer and three individuals char...
Federal Register notice: FDA announces the renewal of its Cellular, Tissue, and Gene Therapies Advisory Committee for an additional two years beyond i...
Two former FDAers list eight key takeaways from the new FDA Omnibus Reform Act.
