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Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

An individual commenter supports the FDA's draft guidance to reduce non-human primate testing but argues that the agency should go further by prioritizing non-animal methods (NAMs) over rodent studies.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.

The commenter supports the draft guidance because it promotes the use of New Approach Methodologies (NAMs) to reduce unnecessary animal testing in oncology drug development.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.

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An individual is writing to support the draft guidance, expressing a desire to reduce animal testing by utilizing existing human data and non-animal models.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.

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 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.

The commenter supports the FDA's effort to reduce unnecessary animal testing in favor of human-relevant evidence like organ-on-a-chip systems and AI. They urge the FDA to strengthen the guidance by clearly defining Weight of Evidence requirements and requiring scientific justifications for any new animal studies.

The commenter supports the FDA's efforts to reduce unnecessary animal testing by prioritizing Weight of Evidence (WoE) packages and modern non-animal methods. They advocate for the inclusion of human data and computational models in regulatory decisions and request that the FDA track and report the effectiveness of these changes in reducing animal studies.

An individual commenter advocates for the reduction of animal testing in pharmaceutical research, urging the FDA to consider alternative methodologies and technologies. They support the proposed action's goal of streamlining nonclinical safety studies by highlighting the public's growing opposition to animal experimentation.