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FDA to hold virtual drug development workshops in July

Registration is open for eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis (July 21) and celiac disease (July 22).
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The Division of Gastroenterology at the FDA’s Center for Drug Evaluation and Research will host the sixth iteration of the Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) workshops on July 21 and 22. Registration for the virtual workshops is open now for any stakeholders interested in drug development for the following topics:

  • Eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis

    July 21, 2021, 10 a.m. – 3:30 p.m. EDT
    This workshop will discuss disease characteristics, natural history and endpoints to assess treatment benefit in patients with eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis.

  • Celiac disease

    July 22, 2021, 9 a.m. – 3:30 p.m. EDT
    This workshop will cover 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.

Questions or concerns may be directed to [email protected].

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