- July 21, 2021
The goal of the GREAT VI workshop is to discuss disease characteristics, natural history, and endpoints to assess treatment benefit in patients with eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis and provide a forum for open discussion between stakeholders to facilitate drug development in these disorders.
About the Workshop
FDA is announcing a public workshop for eosinophilic gastrointestinal disorders. Discussions will focus on eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis and include the following topic areas:
- The diagnosis and natural history of eosinophilic gastrointestinal disorders
- Assessing clinical benefit in eosinophilic gastrointestinal disorders
To participate in the virtual workshop, please register by July 21, 2021 at https://www.eventbrite.com/e/145496486909
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 Eosinophilic Gastrointestinal Disorders Beyond EoE
Date: Jul 21, 2021 09:00 AM Eastern Time (US and Canada)
Access Passcode: =xj6PaJE
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.
Diagnosis and Natural History of EGID
- EGID pathogenesis and nomenclature
- Histopathologic characteristics of EGID: a pathologist’s perspective
- Clinical signs, symptoms, and natural history of EGID
- Alternative etiologies for gastrointestinal mucosal eosinophilia
Assessing Clinical Benefit in EGID
- Living with EGID and goals of treatment: a patient perspective
- Defining treatment benefit in clinical trials for EGID: FDA perspective
- Clinician perspective on the assessment of meaningful benefit
For any addition questions or concerns please contact DG Workshops at DGWorkshops@fda.hhs.gov.
|Agenda Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE FINAL||pdf (152.17 KB)|
|GastroenterologyRegulatoryEndpoints_Great_VI_EGID_pdf||pdf (14.17 MB)|
|FDA_EGID Public Workshop Final transcript_pdf||pdf (592.06 KB)|