Regulation· Brief · November 11, 2026, 5:01 AM ET

FDA releases draft guidance on early-phase IND protocols for solid tumors

FDA announced the availability of a draft guidance titled "Early-Phase IND Protocol Recommendations for Solid Tumors" to provide recommendations for sponsors and investigators developing early-phase trials. Comments are due by January 11, 2027, and the guidance covers first-in-human protocols for drugs and biologic products with limited human experience, but does not address hematologic malignancies.

By The Priority Review desk. Machine-summarized from the source above; not independently reported. How we use automation