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Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

The commenter supports the FDA's draft guidance to reduce non-human primate testing but argues that the agency should go further by prioritizing non-animal methods (NAMs) over rodent studies.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 urge the FDA to make weight-of-evidence assessments the default approach and require animal studies only when scientifically justified.

The commenter supports the proposed guidance to streamline nonclinical safety studies for oncology drugs by reducing unnecessary animal testing through weight-of-evidence (WoE) risk assessments. They provide specific recommendations for clarifying evidence requirements, the role of new approach methodologies (NAMs), and species relevance to ensure regulatory predictability.

PhRMA, a trade association representing biopharmaceutical research companies, supports the Draft Guidance for streamlining nonclinical safety studies for biologics and conjugated products. They advocate for greater regulatory predictability, clearer definitions for "well-characterized" payloads, and more explicit guidance on using Weight of Evidence (WoE) frameworks and New Approach Methodologies (NAMs) to reduce animal testing.