# 2026-22970: FDA Drafts Guidance for Early Trials of Solid-Tumor Treatments

2026-22970, Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-11-12, effective 2026-11-12; PRIA reads it as touching household money (as of 2026-11-12).

- Canonical: https://policyrisk.com/federal-register/2026-22970
- As of: 2026-11-12
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-22970
- Title: Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 72873
- Published: 2026-11-12
- Effective: 2026-11-12
- Comments close: 2027-01-11
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-12

## In one line

FDA Drafts Guidance for Early Trials of Solid-Tumor Treatments

## 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!

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Early-Phase IND Protocol Recommendations for Solid Tumors." The purpose of this draft guidance is to provide recommendations to sponsors and clinical investigators developing early-phase trials, which include first-in- human (FIH) protocols or protocols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 Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) and the Office of Clinical Evaluation (OCE) in the Center for Biologics Evaluation and Research (CBER.) This draft guidance is specific to solid tumors and does not address protocols for investigational drugs intended to treat hematologic malignancies.

## Effects PRIA read

- Draft guidance for early-phase solid tumor INDs: benefit, low. 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 diseas…
- Guidance excludes blood cancers: cost, low. 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 protoco…

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## Sources
- [2026-22970 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/12/2026-22970/early-phase-ind-protocol-recommendations-for-solid-tumors-draft-guidance-for-industry-availability)
- [2026-22970 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-12/pdf/2026-22970.pdf)

## Related
- [Previous: 2026-22969, Submission for OMB Review; Comment Request](https://policyrisk.com/federal-register/2026-22969)
- [Next: 2026-22971, Domestic Hemp Production Program; Notice of Request for Extension of a Currentl…](https://policyrisk.com/federal-register/2026-22971)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-22970 (as of 2026-11-12).