Comment from Blavat Andrea
AnonymousSupportIndividual
Summary: The commenter supports the proposed guidance by advocating for a reduction in animal testing. They argue that the FDA should instead rely on a "weight of evidence" approach using human data, published research, and New Approach Methodologies (NAMs) to determine safety.
The FDA should reduce animal testing and adopt a standard guidance which allows companies to answer safety questions by using all the available scientific data, including published research, laboratory studies, human data, and New Approach Methodologies (NAMs)- instead of conducting additional, unnecessary animal studies. A strong weight of evidence package is acceptable proof of safety in cancer drugs and other research studies. This method is more human relevant and spares animal lives!