What is a Serious Adverse Event? | FDA
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What is a Serious Adverse Event? · Death · Life-threatening · Hospitalization (initial or prolonged) · Disability or Permanent Damage · Congenital ... Skiptomaincontent SkiptoFDASearch Skiptointhissectionmenu Skiptofooterlinks Inthissection: Rep
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An adverse event or suspected adverse reaction is considered "serious" if, in the view of either ...
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What is a Serious Adverse Event? · Death · Life-threatening · Hospitalization (initial or prolon...
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