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Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
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Search interest data over the past 12 months indicates that this topic periodically attracts global attention. Sudden spikes often correlate with major news events, public statements, or geopolitical developments.