Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods

Posted 09 October 2017 By Josy Giordano-Schaefer, PhD, Manfred Ruthsatz, PhD, Heinrich Schneider, MD

placeholder+image This article compares the legal definitions of drugs and medical food and outlines the distinctive regulatory hurdles for medical food, in particular, the need for substantiating distinctive nutritional requirements. The authors also make recommendations on how those regulatory hurdles could be overcome with definitive regulatory guidance for both distinctive nutritional requirements (DNR) and modification of normal diet alone (MODA).

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Categories: Features, US, FDA

Tags: Medical Food

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