Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access
Funds research using data from expanded access to investigational drugs for people with ALS who are not eligible for any ongoing trial.
People with amyotrophic lateral sclerosis who do not meet the entry criteria for any running trial can sometimes still receive an investigational drug, through the expanded access route in federal drug law. Until now, almost nothing has been learned from them. This notice changes that.
The legal basis is named directly: expanded access for investigational drugs or biological products as set out i…
Scientific research using data from expanded access to investigational drugs or biological products under section 561 of the Federal Food, Drug, and Cosmetic Act, targeting intermediate-size populations of people with amyotrophic lateral sclerosis who are not eligible for ongoing clinical trials, covering prevention, diagnosis, mitigation, treatment or cure. A clinical trial is required.
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