Crohn's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Crohn's Disease: Developing Drugs for Treatment." This draft guidance addresses FDA's current thinking about necessary attributes of clinical trials for developing drugs for the treatment of Crohn's disease in adults, including recommendations for trial population, trial design, and efficacy and safety considerations.
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