BRIEF—FDA publishes final guidance on ALS drug development

The US Food and Drug Administration (FDA) has published its final guidance for industry on development drugs for the treatment of amyotrophic lateral sclerosis (ALS).

This guidance provides industry with the FDA’s current scientific thinking so that effective treatments with a favorable benefit to risk profile can be most efficiently developed, studied and ultimately made available to patients with the neurological condition.

The agency has drawn up the document with input from patients, researchers and advocates.