|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA Announces Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshops FDA is announcing two Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) workshops on July 21 and July 22. Both public workshops are virtual and free to attend. The GREAT VI workshop on eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis will be held on July 21, 2021, from 10 a.m. to 3:30 p.m. EST. The workshop will discuss disease characteristics, natural history, and endpoints to assess treatment benefit in patients with eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis. The workshop will provide a forum for open discussion between stakeholders to facilitate drug development in these disorders. Participants should register for the workshop before attending. The GREAT VI workshop on celiac disease will be held on July 22, 2021, from 9:00 a.m. to 3:30 p.m. EST. The workshop will 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. Participants should register for the workshop before attending. For any additional questions or concerns, please contact DG Workshops at DGWorkshops@fda.hhs.gov. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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