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Off-label dissemination "safe harbor" approach proposed in industry-backed compromise.

Executive Summary

INFORMATION DISSEMINATION BILL INDUSTRY-BACKED COMPROMISE proposes a "safe harbor" approach, which would define particular circumstances under which companies could freely disseminate off-label information without FDA approval. The "safe harbor" measure has been floated by industry for consideration by legislators who are seeking a bipartisan consensus on off-label dissemination.
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PS028273

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