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'Off-Label' Communications That Are Still 'Consistent' With Labeling Get Better Defined

 
• By Brenda Sandburg

US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.

FDA entrance sign 2016

The US FDA is providing more details on the kinds of information that firms can communicate about their products that would be consistent with FDA-required labeling in a final guidance.

The document, "Medical Product Communications That Are Consistent with the FDA-Required Labeling – Questions and Answers," is similar to a draft guidance issued in January 2017, as it retains the three-factor test to determine if a communication about a product that is not in the label is in alignment with the labeling

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