FDA warns Indias Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a bioequivalence study...
FDA warns Israels Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violations.
FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was preparing to remove him....
Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.
An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project focused on novel biomar...
Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased risk of serious seconda...
A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing facility in Windsor, ...
An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
