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- Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System after sheath tip separation reportsBoston Scientific announced a recall of its ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus. The FDA classified the recall as the most serious…
- Industry groups call for clearer FDA guidance on QRIs in expedited IND pilotPharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies. The groups say the FDA need…