On Friday, May 27th, 2026, the FDA issued a new draft guidance: "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products". It is a very short guidance at just 4 pages, but aligns well with the past year's publications, announcements, and guidance on reducing animal use, including Weight of Evidence and inclusion of NAMs.
Some highlights from the text:
"This guidance is intended to facilitate drug development for biologics and conjugated products for the treatment of cancer while avoiding unnecessary animal use."
"This guidance provides recommendations for general toxicology studies with a primary focus on 3-month toxicology studies for certain oncology pharmaceuticals."
"Sponsors may propose alternative approaches for a 3-month general toxicology study for product classes not described in this guidance, provided such approaches are sufficient to address product safety. Such approaches for a 3-month general toxicology study may include a non-sacrificial toxicology study, an alternative study design to reduce animal numbers, or a weight of evidence (WoE) risk assessment for products with well-understood targets to replace an animal study. These approaches could be supplemented with new approach methodologies (NAMs), as appropriate. Sponsors proposing alternative approaches not specifically addressed in this guidance should provide appropriate scientific justification and relevant supporting data. The Agency will consider whether the alternative approach is adequate to characterize the safety risks in each case."
"Additionally, sponsors may consider conducting 3-month toxicology studies early in development, in lieu of separate 1-month and 3-month toxicology studies, to reduce animal use."
The subsequent Recommendations and Weight of Evidence Risk Assessment sections include a number of options for sponsors to consider.
This link takes you to the announcement page that includes the link to the actual draft guidance:
Streamlined nonclinical studies
| U.S. Food and Drug Administration |
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#fda #streamlined #Oncology
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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