Comment from American Association of Pharmaceutical Scientists (AAPS)

Summary: The American Association of Pharmaceutical Scientists (AAPS) supports the FDA's effort to streamline nonclinical safety studies for oncology biologics and conjugated products. They recommend providing more specific guidance on how to select alternative study designs, clarifying the role of new approach methodologies (NAMs), and ensuring the weight-of-evidence (WoE) framework is structured to improve predictability for sponsors.