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Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

An individual commenter supports the FDA's draft guidance to reduce non-human primate testing but argues that the agency should go further by prioritizing non-animal methods (NAMs) over rodent studies.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The commenter supports the draft guidance because it promotes the use of New Approach Methodologies (NAMs) to reduce unnecessary animal testing in oncology drug development.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.

An individual commenter supports the proposed action to streamline nonclinical safety studies by advocating for the use of alternative testing methods, such as AI, to avoid harming animals. The commenter expresses a personal commitment to boycotting companies that utilize animal testing.

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 supports the proposed action to streamline nonclinical safety studies, arguing that animal testing is cruel, scientifically unreliable, and should be phased out in favor of more reliable data collection methods.

The commenter supports the FDA's efforts to streamline nonclinical safety studies by reducing redundant animal testing and promoting New Approach Methodologies (NAMs). They advocate for improved data-sharing practices, standardized biomedical data (FAIR principles), and increased funding for data stewardship to enhance the efficiency and human relevance of drug development.

The commenter supports the draft guidance to reduce animal testing through Weight of Evidence approaches but urges the FDA to provide more specific examples, clarify Generally Accepted Scientific Knowledge (GASK), and address right-to-reference barriers. They argue that clearer regulatory pathways are necessary to give sponsors the confidence to move away from animal models toward non-animal alternatives.

Michelle Wood expresses support for the draft guidance to streamline nonclinical safety studies for oncology pharmaceuticals. She advocates for the FDA to prioritize the use of modern, non-animal alternatives (NAMs) like organ-on-a-chip systems and computer modeling to improve drug safety and animal welfare.