Informational Webinar for Applicants to NINDS ALS Expanded Access (U01) - October 2026

This webinar aims to inform potential grant applicants and answer questions about the NINDS Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) RFA-NS-26-001. The goal of this announcement is to support the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products for patients living with ALS who are not eligible for ongoing ALS clinical trials. This webinar provides an overview of the funding opportunity, including requirements and eligibility, and includes a Q&A session.

Section 2 of the Accelerating Access to Critical Therapies (ACT) for ALS Act established a grant program for scientific research utilizing data from expanded access to investigational drugs for individuals who are not otherwise eligible for clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis (ALS). 

NIH released RFA-NS-26-001 to implement Section 2 of ACT for ALS. In the frequently asked questions (FAQs), we have pointed out the relevant sections of ACT for ALS that establish the requirements of this NIH grant program.

Eligibility Requirements: See ACT for ALS Sec. 2(e) for definition of participating entity and participating clinical trial, and Sec. 2(a) for expanded access New Drug Application (IND) authorization requirements.

Resources

2026 EAP FAQs(pdf, 528 KB)