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If The ‘SIUU’ Fits: The New Vocabulary Of US FDA ‘Off-Label’ Policy

 
• By Michael McCaughan

An updated US FDA policy governing dissemination of ‘off-label’ journal reprints and other scientific communications suggests the agency feels on firmer legal ground to reaffirm some guardrails. It also expands the regulatory vocabulary to include ‘scientific information on unapproved uses,’ or SIUU.

stethoscope and literature
• Source: Shutterstock

A newly updated US Food & Drug Administration guidance for sponsors on dissemination of journal articles and similar content that discusses “off-label” uses of approved therapies introduces a new item to the lexicon of regulatory jargon: SIUU, or “scientific information on unapproved uses.”

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