FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the Totality of the Evidence

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 drugs and devices....
By: Hogan Lovells

Hogan Lovells