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

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

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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...

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