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GUIDANCE DOCUMENT

Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment October 2009

Draft

Not for implementation. Contains non-binding recommendations.

Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by Helicobacter pylori (H. pylori) for the reduction of duodenal ulcer recurrence. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs to support antimicrobial-containing H. pylori treatment regimens. This guidance intends to serve as a focus for continued discussions among the Division of Special Pathogen and Transplant Products, pharmaceutical sponsors, the academic community, and the public. As the science of this indication evolves, this guidance may be revised as new information accumulates.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.