Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry
This guidance document is being distributed for comment purposes only. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS.