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The FDA’s recent announcement to reduce, and in some cases replace, animal testing for monoclonal antibodies and other therapeutics represents one of the most consequential regulatory developments in drug development in decades.
If implemented effectively, it will reshape how new biologic medicines reach patients and how regulators evaluate safety in the era of precision therapeutics. For clinicians, the shift has direct implications for how the safety and predictability of emerging biologic therapies will be assessed before they reach the clinic.
Although widely described as a “paradigm