Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

An individual commenter supports the FDA's draft guidance to reduce non-human primate testing but argues that the agency should go further by prioritizing non-animal methods (NAMs) over rodent studies. They advocate for a weight-of-evidence approach that requires scientific justification for any animal testing that cannot be replaced by human-relevant technologies.

An individual expresses strong opposition to the proposed guidance based on ethical concerns regarding animal testing. The commenter argues that animal suffering should be eliminated and suggests using human subjects instead.

An individual expresses strong opposition to the proposed guidance based on ethical concerns regarding animal testing. The commenter argues that animal suffering should be eliminated and suggests using human subjects instead.

The commenter supports the draft guidance because it promotes the use of New Approach Methodologies (NAMs) to reduce unnecessary animal testing in oncology drug development. They argue that NAMs are more cost-effective, faster, and potentially more predictive of human responses than traditional animal models, ultimately accelerating patient access to cancer therapies.

The commenter supports the move toward streamlined nonclinical safety studies by arguing that animal testing is often ineffective and morally wrong. They advocate for the abandonment of animal testing in favor of non-animal protocols.

An individual commenter opposes the proposed guidance, expressing strong emotional distress over the use of animals in drug testing. They advocate for a transition to non-animal testing technologies and suggest using human prisoners as an alternative.

A private citizen requests that the FDA provide clearer definitions for what constitutes a "strong Weigh of Evidence Package" to help researchers determine when animal studies can be avoided. The commenter advocates for the use of human data and non-animal methods to reduce the reliance on animal testing.

An individual is writing to support the draft guidance, expressing a desire to reduce animal testing by utilizing existing human data and non-animal models. They request that the FDA clarify "Weight of Evidence" standards, track the guidance's effectiveness in reducing animal studies, and allow researchers more time to strengthen existing evidence.

The commenter supports the FDA's efforts to streamline nonclinical safety studies by advocating for the use of the best available science to reduce unnecessary animal testing. They emphasize that protecting human health and eliminating animal testing can be achieved simultaneously through evidence-based decision-making.