Irritable Bowel Syndrome — Clinical Evaluation of Products for Treatment

Guidance for Industry
Irritable Bowel Syndrome — Clinical Evaluation of Products 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DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Ruyi He at 301-796-0910 or Ann Marie Trentacosti at 770-716-9984.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
March 2010
Clinical/Medical
I:\4690dft.doc
3/4/2010

open here to see the full-text:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM205269.pdf