Eosinophilic esophagitis: developing drugs for treatment

Eosinophilic esophagitis: developing drugs for treatment

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Development
Eosinophilic Esophagitis -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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. This guidance does not address the clinical development of drugs for the treatment of non-EoE, eosinophilic gastrointestinal disorders.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (11 pages)).
NLM Unique ID:
9918232103706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918232103706676