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# FDA Progressing Toward Replacing Animal Testing :Study
- URL: https://www.fdaweb.com/fda-progressing-toward-replacing-animal-testing-study/
- Published: 2026-06-25T12:00:00.000Z
- Updated: 2026-09-14T13:41:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161381

A newly published [commentary](https://link.springer.com/article/10.1186/s13287-026-05090-6?ref=fdaweb.com) in the journal *Stem Cell Research & Therapy* says FDA’s efforts to reduce reliance on animal testing is driving a fundamental shift toward human-based technologies for evaluating drug safety. The article reviews the agency's first-year progress under its roadmap to reduce animal testing requirements, an initiative launched in 2025 that promotes the use of New Approach Methodologies (NAMs) such as organoids, organs-on-chips, computational modeling, and artificial intelligence-based tools. The authors argue that traditional animal models often fail to accurately predict human responses, noting that more than 90% of drug candidates that appear successful in animal studies ultimately fail in clinical development.

Among FDA's key accomplishments, the authors cite the establishment of agency-wide NAM review structures, the permanent adoption of the Innovative Science and Technology Approaches for New Drugs program, publication of human-centric validation principles for alternative testing methods, and draft guidance streamlining nonclinical safety testing for monoclonal antibodies.

The paper also highlights growing international alignment among regulators, including FDA, the European Medicines Agency, Japan's Pharmaceuticals and Medical Devices Agency, and Australia's Therapeutic Goods Administration, aimed at harmonizing standards for alternative testing approaches.

Despite the progress, the authors caution that significant challenges remain, including limited validated alternatives for developmental toxicity, carcinogenicity, and long-term safety studies, as well as resistance to adopting new methods across industry and regulatory organizations.

The commentary concludes that the FDA's roadmap could ultimately make animal studies the exception rather than the norm in drug development, while potentially reducing clinical trial failures, accelerating patient access to new therapies, and improving the scientific relevance of nonclinical safety testing.