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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