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2/15/2018

The Celiac Disease Foundation Submits Comment to FDA on Draft Guidance Regarding Gluten in Medications

On December 12, 2017, the Food & Drug Administration (FDA) issued guidance to drug manufacturers to voluntarily label medications that do not contain gluten with the following statement: “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).” The FDA granted a 60 day period to submit comments and suggestions regarding this draft…

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1/10/2018

Marilyn’s Message January 2018

“Fail faster” is a saying in drug research. In 2014, the Tufts Center for the Study of Drug Development estimated that the average cost of bringing a new drug through the development pipeline and Food and Drug Administration (FDA) approval process to market is $2.6 billion. More than 90 percent of all drugs being developed…

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9/19/2017

How Will New FDA Strategies to Evaluate Benefits vs. Risks Impact Drug Development and Approval for Celiac Disease, Non-Celiac Gluten/Wheat Sensitivity, and Their Comorbidities?

On September 18, 2017, Celiac Disease Foundation (CDF) representatives attended a Food and Drug Administration (FDA) meeting in White Oak, MD on the ongoing implementation of a benefit-risk framework to inform drug and medical device review and approval processes. Under legislative mandate, the FDA is seeking to formally incorporate the patient experience and perspective into…

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6/7/2017

New Sampling Data on Compliance with FDA Gluten-Free Labeling Rule

On August 2, 2013, the Food and Drug Administration issued a final rule defining “gluten-free” for food labeling to help consumers, especially those living with celiac disease and non-celiac gluten/wheat sensitivity, trust that items labeled “gluten-free” meet a defined standard for gluten content. This rule was officially implemented one year later in August of 2014. Bringing…

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