5:47 AM
 | 
Jun 12, 2018
 |  BC Extra  |  Politics & Policy

FDA provides guardrails for communicating beyond the label

FDA published guidance Tuesday about manufacturer communication of information that is consistent with, but is not contained in, an FDA-approved label.

The agency stated in the guidance that communications consistent with a label will not be considered promotion of a new intended use. Promotion of a new intended use can lead to prosecution for illegal off-label promotion.

FDA will take three factors into...

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