Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery revascularization.
CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised procedures and adding medical devices to the formal dispute resolution process
Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery revascularization.
CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised procedures and adding medical devices to the formal dispute resolution process
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 generated in China, citing concerns about transparency and potential underreporting of serious adverse events and patient deaths.
