House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on clinical trial data ge...
CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised proc...
FDA issues a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns therapeutic equivalence c...
CDRH issues an Early Alert after becoming aware that GE HealthCare sent a letter alerting affected customers of updated use instructions for Portrait ...
FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.
FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and ...
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
