FDA Drafts Guidance for Early Trials of Solid-Tumor Treatments
Published Date: 11/12/2026
Notice
Summary
The FDA just dropped a draft guide to help drug makers and researchers design early tests for new cancer drugs targeting solid tumors. If you’re working on first-time human trials or new biologic treatments, this guide shows you the ropes to get your protocols right. Comments are open until January 11, 2027, so jump in now to shape the final rules and speed up lifesaving treatments!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Draft guidance for early-phase solid tumor INDs
If you are a drug sponsor or clinical investigator designing an early‑phase investigational new drug (IND) protocol—including first‑in‑human (FIH) or drugs/biologics with limited human experience—for solid tumors, the FDA published a draft guidance with recommendations for submissions to the disease‑specific divisions in the Office of Oncologic Diseases (OOD) in CDER and the Office of Clinical Evaluation (OCE) in CBER. The agency posted the draft guidance on November 12, 2026 and is accepting comments through January 11, 2027. The document is a draft that represents FDA’s current thinking and is not binding; you may use alternative approaches that meet applicable statutes and regulations.
Guidance excludes blood cancers
The draft guidance applies specifically to solid tumors and explicitly does not address protocols for investigational drugs intended to treat hematologic malignancies. If you are developing early‑phase IND protocols for hematologic (blood) cancers, this draft guidance does not apply to your protocols.
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