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Regulatory, Technical and Formulations for New Infant Formula Notifications – Challenges and Opportunities

The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies not well-prepared for the rigors of FDA review and assessment.

New NDI Guidance – Still a Work in Progress

By Robert Martin, Ph.D., EAS Senior Advisor for Food & Color Additive Safety On August 11, 2016, FDA issued an updated revised draft guidance on new dietary ingredients used in dietary supplements which replaces draft guidance the agency issued in 2011. FDA...