Comment from PhRMA

Summary: PhRMA, a trade association representing biopharmaceutical research companies, supports the Draft Guidance for streamlining nonclinical safety studies for biologics and conjugated products.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.