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# Draft Guide on Eosinophilic Esophagitis Drug Development
- URL: https://www.fdaweb.com/draft-guide-on-eosinophilic-esophagitis-drug-development/
- Published: 2019-02-06T12:00:00.000Z
- Updated: 2026-09-15T01:01:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143308

FDA has released a draft guidance entitled: “Eosinophilic Esophagitis (EoE): Developing Drugs for Treatment” that assists sponsors with their clinical development of drugs/biologics for treating this condition. The [document](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-D-0177-0002&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) addresses FDA’s current recommendations for clinical trials for such drugs and the necessary attributes of patients for enrollment, efficacy assessments, safety assessments, and pediatric considerations. The guidance does not address the clinical development of drugs for the treatment of non-EoE, eosinophilic gastrointestinal disorders.