FDA Issues Draft Guidance to Reduce Animal Testing for Cancer Drugs

By Katherine Hamilton

The Food and Drug Administration issued draft guidance to reduce animal testing in tests for certain cancer drugs.

The guidance would limit testing deemed unnecessary in nonclinical safety assessments, which would also speed up some regulatory processes, the FDA said Friday.

Under the guidance, the FDA would use a single relevant species instead of two or replace animal studies with evidence-based approaches, the FDA said.

The guidance will provide recommendations for general toxicology studies including when animal testing may be unnecessary because there is no binding or pharmacologic activity.

In some cases, the guidance recommends using rodent studies only or replacing three-month non-human primate studies with a weight-of-evidence risk assessment.

The FDA said the guidance is part of its broader work to reduce the estimated 10 to 12 years it can take to bring new drugs from discovery to patients. It builds on data analysis of toxicology studies and practices to reduce the use of non-human primates.

The FDA is opening the guidance up to public comments until July 30, after which the agency will review and consider comments before finalizing the guidelines.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

May 29, 2026 11:39 ET (15:39 GMT)