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GUIDANCE DOCUMENT

Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry February 2019

Draft

Not for implementation. Contains non-binding recommendations.

Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry

Docket Number:
FDA-2019-D-0177
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Eosinophilic Esophagitis: Developing Drugs for Treatment.” This draft guidance is intended to serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Error Products, pharmaceutical sponsors, the academic community, and the public.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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