Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

The National Institutes of Health (NIH) is soliciting applications for research on the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products as described in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb). These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS. The purpose of this Notice of Funding Opportunity (NOFO) is to support extramural research funded by the National Institute of Neurological Disorders and Stroke (NINDS). Key aspects of the job include: • Conducting scientific research utilizing data from EA for investigational drugs or biological products • Targeting intermediate size populations of patients living with ALS • Supporting extramural research funded by NINDS • Focusing on the prevention, diagnosis, mitigation, treatment, or cure of ALS • Collaborating with NINDS Program Officials and other stakeholders