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Gastroenterology Endpoints To Get Four-Day Series Of FDA Workshops

 
• By Martin Berman-Gorvine

One day each will be devoted to eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease, Sept. 19, 20, 21 and 24, in that order.

FDA’s Center for Drug Evaluation and Research is jumping into a major effort to update regulatory standards with a four-day series of public workshops on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT).

This type of meeting will be increasingly common in coming years, as the latest reauthorization of the Prescription Drug User Fee Act requires the agency to sponsor four disease-specific meetings...

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