Four Validation Pillars Frame US FDA’s New Approach Methodologies For Rx And OTC Drugs Context of use, human biological relevance, technical characterization and fitness for purpose are the key elements in validating novel methods to replace animal testing, the FDA said in a new draft…

The US FDA continues opening the door wider to non‑animal testing. Acceptance will depend on whether a method is proven to be reliable, relevant to humans, and useful for a specific safety decision.

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