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- FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapiesThe U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors.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…
- Acting FDA commissioner reports strong public interest in new expedited IND pilotActing FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…