FDA releases draft guidance to trim animal testing in cancer drug development
The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs.
The guidance suggests using a single relevant species instead of two, limiting studies to rodents when appropriate, and replacing lengthy nonhuman primate studies with weight-of-evidence risk assessments that may incorporate New Approach Methodologies.
If finalized, the recommendations could streamline toxicology requirements, potentially shortening the lengthy drug development timeline and aligning with the agency’s commitment to both faster approvals and reduced animal use.
This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs”
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