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GUIDANCE DOCUMENT

Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products Draft Guidance for Industry December 2021

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2021-D-0406
Issued by:
Guidance Issuing Office
Center 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0406.

 
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