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Off-Label Use Regulatory Standards

Hogan Lovells

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in...

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In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

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