The FDA has released a draft guidance, Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products (May 2026), with comments due by July 30, 2026.
This draft guidance aligns with FDA's efforts to reduce reliance on animal testing and outlines approaches for evaluating the safety of certain oncology biologics and conjugated products, including antibody-drug conjugates (ADCs), using methods that may provide information equivalent or superior to traditional animal studies.
Topics of interest include:
• New Approach Methodologies (NAMs) and reduction of animal studies
• Nonclinical safety assessment strategies for oncology biologics and conjugated products
• Streamlined toxicology study designs
• Data-driven approaches to justify replacement or reduction of animal testing
We are seeking volunteers to review the draft guidance and participate in the AAPS response team.
Guidance document:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-pharmaceuticals-streamlined-nonclinical-safety-studies-biologics-and-conjugated-products
If you are interested in participating, please contact Joseph Thomas ([email protected]), Kim Huynh-Ba, or me directly.
Thank you!
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Subathra Ramamoorthy
Associate Principal Scientist
Veranova
Westford MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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