US FDA Pushes for New Methods to Replace Animal Testing ...
The FDA's draft guidance and NIH's $150 million funding aim to advance human-relevant new approach methodologies, potentially reducing drug development costs by up to 90%, officials said.
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9 Articles
Health Agencies Ramp Up Push for Alternatives to Animal Testing
Federal regulators on March 18 issued draft guidance to help manufacturers use alternatives to animal testing during drug development, while the National Institutes of Health (NIH) pledged to invest $150 million in research methods that reduce the use of animals. The Food and Drug Administration’s draft guidance says in part that new approaches, such as using organoids—replica organs typically created with stem cells—and computer simulations can…
FDA Proposes More Flexibility in Alternatives to Animal Testing in Drug Development
(MedPage Today) -- Drug developers will be able to use alternatives to animal testing and possibly get new products to market faster under draft guidance issued Wednesday by the FDA. In a press release, officials said the guidance advances the...
FDA, NIH Pledge More Flexibility and $150M Investment for Animal Testing Alternatives
The FDA’s Center for Drug Evaluation and Research (CDER) released new draft guidance March 18 specifying that drug approval applicants are welcome to submit data from new approach methodologies (NAMs) like organoids, organs-on-chips and computational models, even if the method hasn’t previously been OK’d by the agency to replace animals. [FDA (Fierce Biotech)] Press Release
Trump Administration Pushes to End Animal Testing
Federal regulators working on behalf of the Trump Administration issued draft guidance to help manufacturers use alternatives to animal testing during drug development. The Food and Drug Administration’s March 19 guidelines say in part that new approaches, such as using organoids—replica organs typically created with stem cells—and computer simulations can be used for preclinical toxicology and safety testing. The FDA said it was offering the gu…
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