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Guidance Issuing OfficeCenter 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.
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:
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-2009-D-0447.