USA – Guidance : Eosinophilic Esophagitis: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs and therapeutic biologics for the treatment of eosinophilic esophagitis (EoE). Specifically, this guidance addresses FDA’s current thinking regarding clinical trials and development programs for EoE drugs, including recommendations for the necessary attributes of patients for enrollment, trial designs, efficacy considerations, safety assessments, and pediatric considerations…