1. Pink Sheet

Off-Label Communication: When Does It Align With Approved Labeling?

 
• By Brenda Sandburg

US FDA draft guidance offers three-factor test to determine when communication about a medical product is consistent with labeling; information on patient-reported outcomes and mechanism of action are okay.

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FDA is providing clarity on one aspect of off-label communication about medical products: when is it consistent with the product’s approved labeling?

On Jan. 17, the agency issued draft guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” which answers 11 of the most frequently asked questions on...

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