The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Ulcerative Colitis: Clinical Trial Endpoints.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ulcerative colitis (UC) in adult and pediatric patients. Specifically, this guidance addresses FDA's current thinking regarding efficacy endpoints for UC clinical trials.
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Ulcerative Colitis: Clinical Trial Endpoints; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Ulcerative Colitis: Clinical Trial Endpoints.'' The p...
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81 FR 52449
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“Ulcerative Colitis: Clinical Trial Endpoints; Draft Guidance for Industry; Availability,” thefederalregister.org (August 8, 2016), https://thefederalregister.org/documents/2016-18716/ulcerative-colitis-clinical-trial-endpoints-draft-guidance-for-industry-availability.