Comment from The ALS Association

The ALS Association strongly supports FDA’s commitment to modernizing and clarifying the substantial evidence standard. This guidance represents an important opportunity to advance more efficient, scientifically grounded, and patient-centered approaches to drug development for ALS and other serious, life-threatening diseases. We urge FDA to ensure that the flexibility described in this guidance is applied consistently in practice and that evidentiary expectations remain clear, predictable, and aligned with patient needs. At the same time, we value our strong and collaborative partnership with FDA and appreciate the Agency’s continued engagement with the ALS community. Together, we have made meaningful progress in advancing ALS research, regulatory science, and therapeutic development.