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Re: IBS Guidelines
The Irritable Bowel Syndrome is provides its guidelines for Food and Drug Administration’s. This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Here I’m attaching PDF of Irritable Bowel Syndrome guidelines: Table of contents: I INTRODUCTION II BACKGROUND III EVOLUTION OF PRO MEASURES IN IBS CLINICAL TRIALS IV PROVISIONAL ENDPOINTS AND TRIAL DESIGN FOR IBS CLINICAL TRIALS 1 Trial Design 2 Trial Endpoints 3 Trial Populations 4 Efficacy Measures 5 Definition of a Responder V FUTURE DEVELOPMENT OF IBS PRO INSTRUMENTS VI CONCLUSION REFERENCES Contact to: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm. 2201 Silver Spring, MD 20993-0002 |
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