MSB 1.40% $1.09 mesoblast limited

Food and Drug Administration Safety Innovations Act (FDASIA)“The...

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    Food and Drug Administration Safety Innovations Act (FDASIA)

    “The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition...upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonablylikely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.”
 
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