Issue Date: May 29, 2026
Issued by: Oncology Center of Excellence
Topic(s):
Status: Draft
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft Guidance
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 This draft guidance provides recommendations for general toxicology to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of certain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.
Download the Guidance Document
