Tag Archives: fda

The Celiac Disease Foundation Submits Comment to FDA on Draft Guidance Regarding Gluten in Medications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

Marilyn’s Message January 2018

Marilyn Geller

“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 […]

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 […]

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 […]

Partnership with ImmusanT to Promote Phase 2 Clinical Trial of Nexvax2®, A Promising Celiac Disease Treatment

ImmusanT, a Cambridge, MA-based biotechnology company, has announced that Nexvax2®, an immunotherapy drug designed to protect celiac disease patients from gluten exposure, has successfully completed a Phase 1b clinical trial and is advancing to a Phase 2 trial. Currently, strict, lifetime adherence to a gluten-free diet is the only disease management protocol for celiac disease […]

A GREAT Day for Celiac Disease

Celiac Disease Foundation is proud to have been a funder and to participate on the Steering Committee for the FDA Gastroenterology Regulatory Endpoints and Advancement of Therapeutics (GREAT3) workshop. Conceived by Dr. Sonia Kupfer of the University of Chicago and CDF Medical Advisory Board member Dr. Daniel Leffler of Beth Israel Deaconess Medical Center, GREAT3 […]

CDF Attends Precision Medicine Working Group Meeting in Washington D.C.

CDF is committed to advancing the delivery of personalized health solutions emerging from the rapidly developing fields of genomics and data collection and analysis. We are a lead institutional participant in the Community Engaged Network for All (CENA), a ground-breaking initiative to create a massive national patient-driven cohort for disease research. The White House has launched […]

CDF Presents Patient-Focused Celiac Drug Development Survey Data to FDA

On May 11, 2015, the Food and Drug Administration (FDA) will conduct a public meeting on Functional GI Disorders Patient-Focused Drug Development. Celiac Disease Foundation was requested by the FDA to provide commentary about the impact of celiac disease on patients’ daily lives, the types of treatment benefit that matter most to patients, and patients’ […]