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Expanded Access Program (EAP)
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==Serious or life-threatening conditions== Compassionate use is typically restricted to only people with life-threatening or serious illness, which the FDA defines as: {{Quote|text=Serious disease or condition means a disease or condition associated with morbidity that has [[severe and very severe ME|substantial impact on day-to-day functioning]]. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one."|source=Keywords, Definitions, and Resources, Expanded Access β FDA.<ref name="seriouscondition">{{Cite web | url=https://www.fda.gov/news-events/expanded-access/expanded-access-keywords-definitions-and-resources | title = Expanded Access {{!}} Keywords, Definitions, and Resources|website=FDA | date = |access-date=2022-04-13 }}</ref>}} Most programs also require patients to have exhausted all available treatment options or to have no available comparable or satisfactory alternatives for the patient. There are typically other restrictions or limitations as well.<ref name="FDA"/><ref name="EMA"/>
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