Comment from The Cure Coalition

Summary: The Cure Coalition, representing patients and health advocates, supports the FDA's effort to modernize drug development by incorporating New Approach Methodologies (NAMs) while emphasizing that patient safety must remain the primary priority. They argue that the guidance should explicitly require rigorous validation of NAMs, distinguish between different types of animal models, and ensure that NAMs complement rather than replace validated animal studies, particularly for systemic toxicity and vulnerable populations.