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USFDA Guidance: General Considerations for the Use of New Approach Methodologies in Drug Development and Q&A on Pyrogen and Endotoxins Testing
Introduction This guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development" , published as a draft in March 2026 , provides a framework for using New Approach Methodologies (NAMs) in drug development. NAMs include approaches such as: In vitro models (simple and complex systems) In chemico methods In silico modelling The goal of this guidance is to improve human-relevant toxicology prediction and reduce reliance on animal testing. Backg
Sharan Murugan
4 hours ago2 min read