FDA releases draft guidance on alternatives to animal testing in drug development

18th March 2026

Summary:
The US Food and Drug Administration (FDA) has released draft guidance outlining the use of alternatives to animal testing in drug development. The guidance supports the adoption of new approach methodologies, including in vitro tests, computational models and other innovative techniques that can reduce or replace the need for animal studies. It provides recommendations on how these methods can be used to support safety and efficacy assessments, while maintaining regulatory standards. The initiative reflects growing efforts to modernise drug development, improve efficiency and address ethical considerations associated with animal testing. Stakeholders are invited to review the draft and provide feedback as part of the consultation process.

Link: https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-alternatives-animal-testing-drug-development

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