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GUIDANCE DOCUMENT

Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry September 2020

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2019-D-0177
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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All written comments should be identified with this document's docket number: FDA-2019-D-0177.

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