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- FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapiesThe U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
- Intersurgical pulls 22mm smoothbore breathing tubes after FDA warns of detaching connectorsThe FDA Center for Devices and Radiological Health issued an early alert about a potentially high‑risk issue with certain Intersurgical breathing devices. Intersurgical has sent a letter to custom…