WASHINGTON, D.C. — The U.S. Food and Drug Administration has proposed reducing animal testing requirements for certain cancer therapies, a shift that could lower development costs and shorten preclinical timelines for drugmakers while advancing broader efforts to modernize drug safety evaluations.
The agency on Friday released draft guidance outlining when animal studies may be reduced, streamlined or eliminated during nonclinical safety assessments for some oncology biologics and conjugated products.
Under the proposal, developers could in some circumstances use a single animal species instead of two, replace lengthy non-human primate studies with risk-based assessments, or avoid animal testing altogether when a drug shows no relevant biological activity in test species.
The draft guidance applies to general toxicology studies conducted before human clinical trials and is intended to help sponsors generate safety data more efficiently while maintaining regulatory standards.
“This draft guidance not only supports the FDA’s commitment to expedite regulatory pathways for meaningful treatments but also fulfills the agency’s promise to reduce the use of animal testing during drug development,” said Dr. Angelo de Claro, director of the FDA’s Oncology Center of Excellence.
The proposal is part of the FDA’s broader effort to reduce the time required to bring new therapies to market. The agency noted that drug development can take an estimated 10 to 12 years from discovery through patient availability.
The guidance builds on FDA analyses of toxicology data and practices adopted during the COVID-19 pandemic that reduced reliance on non-human primates in some research programs.
In certain cases, the FDA stated that sponsors may be able to substitute traditional animal studies with a weight-of-evidence approach that incorporates alternative scientific tools known as New Approach Methodologies, or NAMs. These methods can include laboratory, computational and other non-animal testing approaches used to evaluate safety risks.
The agency noted that the draft guidance also supplements existing recommendations from the International Council for Harmonisation and previous FDA guidance covering oncology therapeutic radiopharmaceuticals.
The FDA is accepting public comments on the proposal through July 30, 2026, before determining whether to finalize the guidance.
Additional information on the draft guidance is available from the FDA at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-pharmaceuticals-streamlined-nonclinical-safety-studies-biologics-and-conjugated-products
Information on New Approach Methodologies is available at:
https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams
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