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Expanded IND Guidance Threatens Supplement Research, Innovation, Stakeholders Say

 
• By Elizabeth Crawford

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.

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.

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• By Eileen Francis

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More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

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• By Derrick Gingery

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• By Malcolm Spicer

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