FDA Policy/General

House Passes FDA Modernization Act 3.0 for Reducing Animal Testing

The U.S. House of Representatives has passed the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adoption of non-animal testing methods in drug development and align the agency’s regulations with changes Congress enacted four years ago.

The bill, sponsored by Reps. Buddy Carter (R-GA), Nanette Barragán (D-CA), Diana Harshbarger (R-TN), Rosa DeLauro (D-CT), and Troy Carter (D-LA.), now returns to the Senate for final procedural approval before it can be sent to president Donald Trump for his signature. The Senate previously approved identical legislation, S. 355, by unanimous consent in December 2025.

The legislation builds on the FDA Modernization Act 2.0, enacted in 2022, which removed an 84-year-old federal requirement that new drugs undergo animal testing before human clinical trials. Supporters of the latest measure say that while Congress eliminated the statutory mandate, FDA regulations have not been fully updated, creating uncertainty for drug developers seeking to use newer testing technologies.

The FDA Modernization Act 3.0 would direct the agency to revise its regulations to reflect current law and explicitly recognize scientifically validated, human-relevant alternatives to routine animal testing.

The legislation follows a broader FDA effort to reduce reliance on animal studies. In 4/2025, then-FDA commissioner Marty Makary unveiled the agency's Roadmap to Reduce Animal Testing in Preclinical Safety Studies, outlining a strategy to expand the use of alternatives such as organ-on-a-chip systems, organoids, computational modeling, and artificial intelligence in preclinical research.

Supporters argue that these technologies can better predict human responses to drug candidates than traditional animal models. They also point to data suggesting that approximately 90% of drugs that show promise in animal studies ultimately fail during human clinical trials. Advocates also cite animal welfare benefits, noting that hundreds of thousands of laboratory animals continue to be used annually in preclinical drug testing.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome