Search Results for Medical Food

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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