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Free FDA Notices

Guidance on Irritable Bowel Syndrome Products

03/23/2010

Federal Register Notice: FDA is making available a draft guidance for industry, Irritable Bowel Syndrome — Clinical Evaluation of Products for Treatment. It addresses the following three main topics: the evolution of primary endpoints for IBS clinical trials, interim recommendations for IBS clinical trial design and endpoints, and the future development of patient-reported outcome instruments for use in IBS clinical trials. To download this draft guidance, click here. To view this notice, click here.

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