Program report outlines a multicenter expanded access framework for amyotrophic lateral sclerosis across nine centers, highlighting operational pathways for investigational products.
Expanded access (EA) is a Food and Drug Administration-regulated pathway to provide access to investigational products (IPs) to individuals with serious diseases who are ineligible for clinical trials. The aim of this report is to share the design and operations of a multicenter, multidrug EA program for amyotrophic lateral sclerosis (ALS) across nine US centers.
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Neel et al. (2024) studied this question.
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