Contact: Elio Peraza.
Location: This event has ended.
These webinars aim to inform and answer participant questions on the NINDS Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) RFA-NS-24-029. 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. These webinars will provide an overview of the funding opportunity, including requirements and eligibility, and will include a Q&A session.
All investigators interested in learning about the NINDS ALS Expanded Access program are encouraged to register and participate. You are also encouraged to submit questions before the meeting to Elio Peraza.
Frequently Asked Questions
FAQs Expanded Access RFA Webinar(pdf, 358 KB)
Webinar slides(pdf, 2847 KB)
The Accelerating Access to Critical Therapies (ACT) for ALS Act was passed into law on December 23, 2021 (P.L. 117-79). Section 2 authorized 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). The statute limits the grant program to phase 3 clinical sites sponsored by a small business concern.
NIH released RFA-NS-24-029 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.
Contact Information
Please direct all inquiries to:
Amy Tsou, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)/Division of Clinical Research
Email: amy.tsou@nih.govEmily Caporello, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)/Division of Translational Research
Email: emily.caporello@nih.govAmelie Gubitz, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)/Division of Neuroscience
Email: gubitza@nih.gov