Core Viewpoint - Vanda Pharmaceuticals calls for stronger FDA action to accelerate the transition from animal testing to human-relevant methods in drug development, expressing concerns over the FDA's draft guidance released on March 18, 2026 [1][2]. Summary by Sections FDA Draft Guidance - The FDA's draft guidance aims to support the use of New Approach Methodologies (NAMs) to modernize nonclinical testing and reduce reliance on traditional animal models [2]. - Vanda acknowledges the FDA's commitment to improving human predictivity and ethical standards but believes the draft lacks the necessary reforms for effective implementation [2]. Vanda's Advocacy - Vanda has a history of advocating for science-driven changes, including legal challenges against prolonged animal studies that lack scientific justification [3]. - The company emphasizes the ethical need to minimize animal suffering while advancing predictive human-relevant methods [3]. Key Shortcomings in the Draft - The draft guidance is criticized for vague validation requirements, insufficient transparency, and a lack of concrete examples of accepted NAMs [5]. - There are no specific NAMs mentioned that the FDA currently accepts to replace required animal tests, which creates uncertainty for developers [5]. Recommendations for FDA - Vanda urges the FDA to collaborate with industry innovators and animal welfare groups to refine the guidance [5]. - The company calls for clear pathways for regulatory acceptance that prioritize human relevance and evidence-based confidence [5]. - Vanda suggests incorporating robust citations and specific examples of validated NAMs to enhance the guidance [5][6].