- July 22, 2021
The goal of the GREAT VI workshop is to discuss the overall approach to drug development in celiac disease that includes an assessment of both clinical symptoms and histology. The workshop will focus the discussion on the histologic endpoints to assess treatment benefit in patients with celiac disease; regulatory framework for pediatric drug development in celiac disease; and the role of gluten challenge in clinical trials to provide a forum for open discussion between stakeholders to facilitate drug development.
About the Workshop
FDA is announcing a public workshop for celiac disease. Discussions will focus on the approach to drug development in celiac disease and include the following topic areas:
- The histologic endpoints to assess treatment benefit in patients with celiac disease
- Regulatory framework for pediatric drug development in celiac disease
- The role of gluten challenge in clinical trials
To participate in the virtual workshop, please register by July 22, 2021 at https://www.eventbrite.com/e/145322155479
Agenda (Final) (PDF - 73KB)
A full agenda will be available one week before the workshop.
Topic: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (Great VI): Workshop on Celiac Disease
Date: Jul 22, 2021 08:25 AM Eastern Time (US and Canada)
Access Passcode: E1&n=Y8z
Disclaimer: Please note that the closed-captions for this meeting were auto-generated and may include errors. Please view the full transcript report if you experience closed-caption discrepancies.
Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI):
Workshop on Celiac Disease (PDF - 5.12MB)
For any addition questions or concerns please contact DG Workshops at DGWorkshops@fda.hhs.gov.
|Agenda_noSpeakersNames||pdf (79.42 KB)|
|GREAT VI Meeting Agenda Final||pdf (72.89 KB)|
|GastroenterologyRegulatoryEndpoints_and_theAdvancement_of_TherapeuticsVI(GREAT VI):||pdf (5.12 MB)|
|FDA Celiac Public Workshop Final Transcript_pdf||pdf (748.57 KB)|