Comment from Anonymous
AnonymousSupportIndividual
Summary: The commenter supports the guidance but urges the FDA to use animal testing only as a last resort. They recommend providing clearer definitions for "Weight of Evidence" packets, establishing clear expectations for evidence needed before additional animal studies, and instituting a program to measure the impact of the guidance on reducing animal testing.
Thank you for the opportunity to Public Comment on this Guideline.
Although, I understand the importance of animal testing in the assessment of drug safety for humans, I urge the FDA to limit the use of animal testing as a true last resort.
My recommendations on this particular Guideline are as follows:
1) The FDA should provide researchers with a clearer definition of what constitutes a Strong “Weight of Evidence packet” (WoE).
2) The FDA should provide clearer expectations to help researchers know what evidence is needed prior to more animal studies being considered.
3) The FDA should fully consider ALL available scientific evidence before considering more animal trails.
4) The FDA should institute a program to measure the impact of this guidance on the extent of animal testing. With the goal being the elimination or the drastic reduction of such testing.
5) The FDA should support giving researchers an opportunity to strengthen their existing evidence prior to requesting additional animal studies.