GREAT VI Workshop on Celiac Disease

U.S. Food and Drug Administration

A forum between stakeholders to discuss trial elements to facilitate drug development in celiac disease.

ABOUT THE PUBLIC 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 trialsREGISTRATIONThank you for registering for the Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Celiac Disease. Please use the below meeting link and password to access the workshop. Link: https://fda.zoomgov.com/j/1610231011?pwd=OTU5RUJPOHltQi83UGNGYk5DSmpYUT09Password: PbN&amp;66Attendees will not be permitted access until the start of the meeting at 9am. Closed captions can be accessed during the meeting <a href="https://www.captionedtext.com/client/event.aspx?EventID=4772789&amp;CustomerID=321" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">here</a>. The workshop will be recorded and uploaded to the meeting webpage within one (1) week of the workshop and a full transcript will be available within three (3) weeks. Please check the <a href="https://www.fda.gov/drugs/news-events-human-drugs/gastroenterology-regulatory-endpoints-and-advancement-therapeutics-vi-great-vi-workshop-celiac" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">meeting webpage</a> for updates.MEETING MATERIALSPlease click <a href="https://www.fda.gov/drugs/news-events-human-drugs/gastroenterology-regulatory-endpoints-and-advancement-therapeutics-vi-great-vi-workshop-eosinophilic" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer"></a><a href="https://www.fda.gov/drugs/news-events-human-drugs/gastroenterology-regulatory-endpoints-and-advancement-therapeutics-vi-great-vi-workshop-celiac" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">here</a> to visit the workshop web page to view the final agenda for additional information.ONLINE ATTENDANCE To attend the meeting online, please check your email address for the meeting link. The meeting link will be sent on July 20, 2021. Please note that you will not be permitted login access to the meeting until Thursday, July 22, 2021 at 9:00 amCONTACT INFORMATIONFor any addition questions or concerns please contact DG Workshops at DGWorkshops@fda.hhs.gov.

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GREAT VI Workshop on Celiac Disease

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GREAT VI Workshop on Celiac Disease

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