Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery...
CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised proc...
Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy.
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...
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 warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
