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?:definition
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Specifies whether the product (drug or device) is available for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled study. Expanded Access is a mechanism that provides non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. EXAMPLE(S): OTHER NAME(S): NOTE(S):
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