Implementing Alternative Methods | FDA
FDA’s New Alternative Methods Program is intending to spur the adoption of alternative methods for regulatory use that can replace, reduce, and refine animal testing (the 3Rs), help prevent...
Guidance recommendations for particular in vivo models or study designs, use of pharmacologically relevant animals and qualified alternative methods can replace, reduce and …
FDA Announces Plan to Phase Out Animal Testing Requirement …
Apr 10, 2025 · The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and ...
The FDA gives feedback on NIH/NCATS projects and DOD projects on human tissues from human cells • We are closely following progress • In the near term hope that cells/tissues from …
MPS & the FDA Modernization Act - The 3Rs Collaborative
Rather, the passage of the FDA Modernization Act brings current FDA practice into legislation by formally codifying that non-animal research data can be considered in submissions on efficacy and safety. MPS are a promising technology that can contribute to the refinement, reduction, and replacement of animals in research.
Guidance recommendations for particular in vivo models or study designs, use of pharmacologically relevant animals and qualified alternative methods can replace, reduce and refine animal use.
U.S. FDA unveils new roadmap to replace animal testing
3 days ago · The U.S. Food and Drug Administration (FDA) has released a new roadmap to reduce and replace animal testing in drug development and regulation, in a landmark step towards more ethical and effective science. The agency’s new strategic plan signals a clear commitment to embracing modern, human-relevant approaches and moving away from outdated and unreliable animal-based methods.
Regulatory Applications of 3Rs - National Toxicology Program
Nov 12, 2024 · The FDA Modernization Act 2.0, passed in December 2022, modifies provisions of the Federal Food, Drug, and Cosmetics Act addressing U.S. Food and Drug Administration (FDA) regulatory guidance that requires animal testing for drugs.
MPS for Regulatory Applications - The 3Rs Collaborative
Using microphysiological systems in regulatory applications is a nuanced process that has unique potential benefits and considerations. The 3Rs Collaborative’s MPS initiative works to advance the scientifically supported use of MPS in regulatory applications.
Advancing Alternative Methods at FDA | FDA - U.S. Food and …
FDA is working to advance alternative methods for regulatory use. Alternative Methods have the potential to provide more timely and more predictive information to assess certain aspects of...