Search Results for Medical Food

Showing 1 – 7

Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward By Kathleen D'Hondt, Yolanda Sanz, Manfred Ruthsatz - Published 06 November 2017

This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and drugs to support innovation to benefit society, while guaranteeing safety and efficacy of products and ensuring the science base.

Categories: Features, Europe, US, EC, FDA, Nutritional and dietary supplements

Tags: Microbiome, Diet, Medical Food, Health Claims

Intractable Epilepsy and the Value of Formulated Ketogenic Diet Products By Eric Kossoff, MD - Published 18 October 2017

This article discusses the benefits of the Ketogenic Diet (KD) and the Modified Atkins Diet (MAD) for adults and children as treatments for intractable epilepsy. It offers a patient-oriented interpretation of regulatory requirements for medical foods as well as study data demonstrating KD efficacy. The article was based on a presentation given at the 2017 RAPS Convergence, during the medical food session on Modification of Diet Alone (MODA) vs. access and convenience matters.

Categories: Features, FDA

Tags: Ketogenic Diet, Medical Food

Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods By Josy Giordano-Schaefer, PhD, Manfred Ruthsatz, PhD, Heinrich Schneider, MD - Published 09 October 2017

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).

Categories: Features, US, FDA

Tags: Medical Food

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities By Manfred Ruthsatz, PhD, Timothy Morck, PhD - Published 01 September 2016

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: News, Africa, China, India, Japan, Canada, Europe, Middle East, Oceania, US, FDA, Nutritional and dietary supplements

Tags: Medical Food, Food for Special Medical Purposes

FDA in Sustained Crackdown Against Marketers of Medical Foods By Alexander Gaffney, RAC - Published 21 January 2014

Categories: US, FDA

Tags: Medical Food, warning letter

Medical Foods Can't Treat Alzheimer's Disease, FDA Says in Warning to Company By Alexander Gaffney, RAC - Published 14 January 2014

Categories: US, FDA

Tags: Medical Food, warning letter