Issue Date: November 10, 2026
Issued by: Oncology Center of Excellence
Topic(s): Cancer, Clinical – Medical
Status: Draft
Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry
This document is intended to provide recommendations to sponsors and clinical investigators developing early-phase trials, which include first-in-human (FIH) protocols or protocols for drugs and biologic products with limited human experience, submitted under an Investigational New Drug Application (IND) to the appropriate disease-specific division located within the Center for Drug Evaluation and Research’s Office of Oncologic Diseases (CDER/OOD) and the Center for Biologics Evaluation and Research’s Office of Clinical Evaluation (CBER/OCE). This guidance is specific to solid tumors and does not address protocols for investigational drugs intended to treat hematologic malignancies.
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