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Anglais glossaire

expanded access

Legal use of an investigational drug outside of a clinical trial to treat a person who has a serious or immediately life-threatening disease and who has no approved treatment options. The Food and Drug Administration FDA regulates expanded access to investigational drugs on a case-by-case basis for an individual patient or groups of patients who do not meet criteria to participate in a clinical trial. Drug companies must have permission from the FDA to make an investigational drug available for expanded access. voir également food and drug administration, investigational drug

expanded

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