"The key consideration is scientifically and medically supporting the change in the repurposed drug product by relying on the original drug’s approval data and then “bridging” that data to the repurposed drug under the new conditions of use. Although bridging studies may take the form of pharmacokinetic or bioequivalence studies, in many cases FDA will require the completion of at least one clinical trial to support approval of the repurposed drug. Understanding the nature and impact of the product changes — and what supporting data the FDA will need to see — is therefore critical to receiving approval for a repurposed drug."
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