Comment Deadline: FDA Amyotrophic Lateral Sclerosis – Developing Drugs for Treatment (Draft Guidance)
The Food and Drug Administration (FDA) is seeking public comment on a draft guidance for industry entitled “Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment”. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, it addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS. This guidance addresses the clinical development of drugs intended to treat the main neuromuscular aspects of ALS (i.e., muscle weakness and its direct consequences, including shortened survival).