Ulcerative Colitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Ulcerative Colitis: Developing Drugs for Treatment." This draft guidance addresses FDA's current thinking about necessary attributes of clinical trials for developing drugs for the treatment of ulcerative colitis in adults, including recommendations for trial population, trial design, and efficacy and safety considerations. This draft guidance replaces the draft guidance for industry entitled "Ulcerative Colitis: Clinical Trial Endpoints," which is being withdrawn.
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