Comment from Capitol Hill Consulting Group
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Summary: Charles River Laboratories supports the FDA's draft guidance on New Approach Methodologies (NAMs) but requests additional specificity regarding validation standards, performance criteria, and reporting templates. They emphasize the need for a hybrid approach that balances NAMs with traditional in vivo studies to ensure patient safety and predictable regulatory outcomes.
On behalf of Charles River Laboratories, attached please find comments regarding the draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development.