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There’s No Need To Include Off-Label Use In Labeling, FDA Says In Proposed Rule

After concerns from the medtech industry that a 2017 final rule requires sponsors with knowledge of off-label use of their product to add it to their label, the US FDA is proposing to delete the confusing text.

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The US Food and Drug Administration has proposed updating a rule that, among other issues, would clarify that sponsors do not need to claim intended use of their product solely because it has been used off-label by physicians.

In a 22 September proposed rule, the agency hopes to better define what it means by “intended use” and...

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