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Articles by Manfred Ruthsatz

Foods for special medical purposes/medical foods: A global regulatory synopsis

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By Manfred Ruthsatz, Junshi Chen, Chunzhu Wu, Timothy Morck
| Regulatory Affairs Professionals Society
Foods for special medical purposes/medical foods: A global regulatory synopsis Feature Articles | 31 August 2022 | By Manfred Ruthsatz, PhD, RAC, FRAPS, Junshi Chen, MD, Chunzhu Wu, MSc, Timothy Morck, PhD | PDF | © This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients.
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Human microbiomes in health and disease: Strategic options for regulatory science and healthcare pol | RAPS

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By Manfred Ruthsatz, Nelson Lima, Emmanuelle Voisin, Kathleen D’Hondt
| Regulatory Focus Verified
This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical applicability.
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Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

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By Yolanda Sanz, Manfred Ruthsatz, , Kathleen D'Hondt, Such As MyNewGut, L. S. and Marchesi, Double-Blind Trial, C. A. and Carvalho, OECD Publishing, G. R. and Roberfroid, J. B. and O'Keefe, van Hylckama Vlieg
| Regulatory Affairs Professionals Society
This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease.
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Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods

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By Josy Giordano-Schaefer, Manfred Ruthsatz, Heinrich Schneider
| Regulatory Affairs Professionals Society
Posted 09 October 2017 By Josy Giordano-Schaefer, PhD, Manfred Ruthsatz, PhD, Heinrich Schneider, MD 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.
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