Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products; Draft Guidance for Industry; Availability
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products.'' The purpose of this draft guidance is to provide FDA's current thinking regarding the necessary attributes of patients for enrollment in clinical trials, efficacy assessments, and safety assessments. The draft guidance is intended to serve as a focus for continued discussion among FDA's Division of Gastroenterology, pharmaceutical sponsors, the academic community, and the public.
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