BETHESDA, Md. - Marylandian -- The U.S. Food and Drug Administration (FDA) issued a direct final rule on September 21, updating longstanding regulations to recognize modern, non-animal approaches to drug development. The long-awaited action was examined in an October 5 ABC7/WJLA investigative report led by seasoned journalist Lisa Fletcher, featuring Dr. Zaher Nahle, Founder and CEO of Ivyctory Solutions, and Senior Scientific Advisor at the Center for a Humane Economy.

FDA's action was part of a broader September 21 announcement by the Department of Health and Human Services (HHS), outlining coordinated initiatives across agencies including the National Institutes of Health (NIH) and the Advanced Research Projects Agency for Health (ARPA-H) to expand human-based research, invest in predictive technologies, and reduce reliance on animal testing.

The regulatory update puts into practice the flexibility authorized by FDA Modernization Act 2.0 in 2022 while effectively accomplishing a central objective of the proposed FDA Modernization Act 3.0—aligning FDA regulations with the law.

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The October report revisited Fletcher's December 7, 2025, investigation for Full Measure with Sharyl Attkisson. The original broadcast featured Dr. Nahle alongside then-FDA Commissioner Dr. Marty Makary and Dr. Donald Ingber, founding director of Harvard University's Wyss Institute.

Identified by Fletcher as "an internationally recognized biomedical researcher who specializes in advanced non-animal testing technologies," Dr. Nahle explained: "What the FDA Modernization Act says: let the best method win. Use advanced technologies. Why are we using antiquated animal models that do not work, that do not translate? It's not only the ethical argument, it's the scientific argument."

Beyond the familiar problem of drugs that succeed in animal testing but fail in human clinical trials, Dr. Nahle emphasized a second concern: potentially safe and effective medicines may be prematurely abandoned because of unfavorable animal results.

For Ivyctory Solutions, the coverage underscores the firm's commitment to evidence-based biomedical innovation and its role in providing scientific analysis and strategic insights to inform national discussions on emerging technologies, regulatory modernization, and public policy.

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Read the ABC7/WJLA investigation: https://wjla.com/features/i-team/animal-testing-organs-on-chips-nonanimal-fda-methods-drug-development-modernization-act-20-human-trials-moderna

About Ivyctory Solutions

Ivyctory Solutions is a market research and strategic advisory firm specializing in biomedical innovation, life sciences, regulatory affairs, and public policy. The firm provides evidence-based analysis, market intelligence, and strategic insights to inform decision-making, evaluate emerging technologies, and navigate evolving scientific and regulatory landscapes.

Website: https://www.ivyctory.com/