Comment from Pfizer
AnonymousSupportIndividual
Summary: The commenter suggests updating the draft guidance to explicitly allow for the use of non-animal models (NAMs) as an alternative to traditional 14-90 day in vivo studies. They provide specific proposed language to incorporate into the document to align with the FDA Modernization Act 2.0.
Consistent with the FDA Modernization Act 2.0, suggest incorporating verbiage allowing the use of non-animal models (i.e., new approach methodologies [NAMs]) as an alternative to 14-90 day in vivo studies. This impacts lines 212-215, 271-273 and 308-310. Proposed text that could be used:“...applicants should submit a justification for the safety of the impurity or degradation product at the proposed limit (e.g. repeat-dose general toxicology study using the appropriate route of administration and doses, and of 14–90 days in duration, depending on the chronicity of the indication, or an appropriate non-animal model i.e., new approach methodologies [NAMs]).