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FDA Unveils Roadmap to Replace Animal Testing with Human-Relevant Methods

The agency launches a pilot program for monoclonal antibody therapies, leveraging AI, organoids, and organ-on-a-chip systems to modernize drug evaluation.

Overview

  • The FDA announced plans to phase out animal testing requirements for monoclonal antibody therapies and other drugs, focusing on alternative testing methods.
  • New approaches include AI-based toxicity models, lab-grown organoids, and organ-on-a-chip technology to better predict human drug responses.
  • A pilot program will allow select developers to use primarily non-animal testing strategies, with updated guidelines incentivizing their adoption.
  • The initiative aims to accelerate drug development, improve safety, reduce research costs, and address ethical concerns over animal experimentation.
  • Financial markets reacted sharply, with stocks of companies providing alternative testing technologies surging, while those reliant on animal testing, like Charles River Laboratories, saw declines.

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