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

Executive Summary

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.

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