GUIDANCE DOCUMENT
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products Draft Guidance for Industry December 2021
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2021-D-0406
- Docket Number:
- FDA-2021-D-0406
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to help sponsors in the clinical development of products for bowel cleansing in fically, preparatioopy . Specithis guidance describes the Food and Drug Administration’s (FDA’s) current thinking about the necessary attributes of clinical trials for drugs being developed under Section 505 of the Food, Drug, and Cosmetic Act (21 U.S.C §355) and 21 CFR Parts 312 and 314 for use as bowel cleansing agents before colonoscopy, including trial population, trial designs, efficacy considerations, and safety assessments.