Expanded Access Navigator
Expanded Access Navigator launched by Reagan-Udall Foundation in collaboration with patient advocacy groups, pharmaceutical industry, FDA, and Federal government
- online tool to guide patients, caregiver, physicians, through process for requesting single-patient expanded access for unapproved investigational drugs
- for patient who has serious or immediately life-threatening disease or condition for which there is no FDA-approved treatment
- permits the product’s manufacturer, with FDA authorization, to provide investigational drug for patient
- physician submits Single Patient Expanded Access request
Image Credit: Reagan-Udall Foundation for the FDA
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