Drug Information Update- New Draft Guidance: H. pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment

Drug Information Update- New Draft Guidance: H. pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled ‘‘Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by H. pylori for the reduction of duodenal ulcer recurrence. Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs to support antimicrobial-containing H. pylori treatment regimens.
You may view this guidance at: H. pylori
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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184500.pdf