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An Entity of Type : prov:Entity, within Data Space : webisa.webdatacommons.org associated with source dataset(s)

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  • This subpart does not apply to products that can be approved based on efficacy standards described elsewhere in FDA's regulations (e.g., accelerated approval based on surrogate markers or clinical endpoints other than survival or irreversible morbidity), nor does it address the safety evaluation for the products to which it does apply.
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