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

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

DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the 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 docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact Joette Meyer at 301-796-1600.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
October 2009
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abrir aquí para acceder al documento PDF de la FDA:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184500.pdf