In recently issued guidance, FDA extends requirements for investigational new drug applications to dietary supplement studies focusing on disease endpoints, creating a paradoxical situation that could block firms from marketing new dietary ingredients (NDIs) and discourage innovation, stakeholders say.
Expanded IND Guidance Threatens Supplement Research, Innovation, Stakeholders Say
Recent FDA guidance indicating that dietary supplement clinical studies with disease endpoints require an IND application could render the sale of some new dietary ingredients in foods unlawful, CRN argues. The expanded scope of FDA’s requirements for IND applications further adds unnecessary regulatory barriers and costs, CHPA and others add in comments to the agency.
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