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GUIDANCE DOCUMENT

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products Draft Guidance May 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2026- D-2839

Docket Number:
FDA-2026- D-2839
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

In line with the FDA Roadmap to reduce animal testing in product development and based on the FDA Review Division’s experience and data analysis, the Agency is communicating approaches to evaluate the safety of certain oncology pharmaceuticals, which provide safety information that is equivalent or superior to animal studies. These approaches will result in more efficient product development and will eliminate or reduce unnecessary animal studies. This draft guidance provides recommendations for general toxicology to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of certain oncology pharmaceuticals.

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