Federal Register #2026-22970

FDA Draft Guidance on Early-Phase IND Protocols for Solid Tumor Trials

The FDA is seeking public input on draft recommendations for early-phase investigational trials involving solid tumors. - Government buyer/issuer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). The guidance involves disease-specific divisions within the Office of Oncologic Diseases (OOD), Center for Drug Evaluation and Research (CDER), and the Office of Clinical Evaluation (OCE), Center for Biologics Evaluation and Research (CBER). - Scope: Recommendations are for sponsors and clinical investigators preparing early-phase protocols submitted under an Investigational New Drug (IND) application, including first-in-human trials and trials of drugs or biologic products with limited human experience. - Notable limitation: The guidance covers solid tumors and does not address investigational drugs for hematologic malignancies. - Procurement status: This is a draft guidance announcement, not a procurement or contract award. No products, services, quantities, OEMs, or vendors are identified; FDA is inviting public comments.

Description

The FDA announces the availability of draft guidance titled “Early-Phase IND Protocol Recommendations for Solid Tumors.” It provides recommendations for sponsors and clinical investigators developing early-phase trials, including first-in-human protocols and protocols for drugs or biologic products with limited human experience, submitted under an Investigational New Drug Application (IND). The guidance applies to solid tumors and does not address investigational drugs intended to treat hematologic malignancies. Comments are due January 11, 2027.

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