Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis; Public Hearing

摘要

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on the Agency's regulation of drugs for the treatment and/or management of amyotrophic lateral sclerosis (ALS). FDA is holding this public hearing to allow patients, caregivers, advocates, health care providers, academia, industry, and other interested persons to give their perspectives on various aspects of the development of drugs for the treatment or management of ALS. The input from this public hearing will help inform the work of FDA offices that review applications for drugs for the treatment of ALS.