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Written Presentation to FDA September 12, 2017

On September 12, 2017, Ceciel Rooker presented the following research information to the US Food and Drug Administration (FDA) concerning the burdens and needs of gastroparesis patients:

On behalf of the International Foundation for Functional Gastrointestinal Disorders (IFFGD), we appreciate the opportunity provided by the FDA to hear the patient perspective at the Patient-Focused Drug Development public meeting on Functional GI Disorders held on May 11, 2015.

I am pleased to follow-up on our participation at that meeting and share with you the results of a peer-reviewed online survey we conducted in collaboration with investigators from Temple University School of Medicine. The data from this research looks at burdens, concerns, and quality of life of 1,423 adults in the general community diagnosed with gastroparesis. Attached (PDF) is a Summary Report. The full study results were published in the journal, Digestive Diseases and Sciences (Yu D, Ramsey FV, et al. The burdens, concerns, and quality of life of patients with gastroparesis. Dig Dis Sci. 2017 Jan 12. doi:10.1007/s10620-017-4456-7).

We appreciate your continuing efforts at the FDA to learn the perspective of patients as you seek to understand and help meet the needs of people with gastroparesis and other functional GI disorders. Thank you.


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