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Crohn’s Disease: Developing Drugs for Treatment April 2022

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Crohn’s Disease: Developing Drugs for Treatment.” This draft guidance addresses FDA’s current thinking about necessary attributes of clinical trials for developing drugs for the treatment of Crohn’s disease in adults, including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.

Submit Comments

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0091.

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