Celiac Support Association

Call to Action - “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).”

The public workshop March 30 and 31, 2015, from 8:30 a.m. to 5 p.m.

View Slide Show Presentations 

Federal Register Notices 

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Action

Notice of public workshop.  AGENDA  Presentation PDF's 

Summary

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the North American Society for the Study of Celiac Disease, and the Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).” The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease.

Dates

The public workshop March 30 and 31, 2015, from 8:30 a.m. to 5 p.m.

Supplementary Information

This workshop will address endpoints for registration trials in inflammatory bowel diseases and celiac disease. Stakeholders, including industry sponsors, academia, patients and FDA, will address challenging issues related to selection of endpoints and assessment methodologies in clinical trials intended to support approval of products for treatment of inflammatory bowel diseases and celiac disease. The first day of the workshop will discuss the assessment of efficacy in Crohn's disease trials, including the use of patient-reported outcome measures and endoscopic evaluation, as well as the role of registries and patient participation in inflammatory bowel disease drug development programs. The second day of the workshop will discuss the appropriate target population for pharmacological therapy in celiac disease, and the definition and measurement of a treatment benefit in celiac disease registration trials, including the role and timing ofassessment of histological and serological endpoints.

II. Transcripts

Transcripts of the workshop will be available for review at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the Internet at http://www.regulations.gov approximately 30 days after the workshop. A transcript will also be available in either hard copy or on CD-ROM after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Fax requests to 301-827-9267.

Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01625 Filed 1-28-15; 8:45 am]
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