U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Crohn’s Disease: Developing Drugs for Treatment
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Crohn’s Disease: Developing Drugs for Treatment April 2022

Download the Draft Guidance Document Read the Federal Register Notice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

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0091
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Crohn’s Disease: Developing Drugs for Treatment.” This draft guidance addresses FDA’s current thinking about necessary attributes of clinical trials for developing drugs for the treatment of Crohn’s disease in adults, including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

Submit Comments Online

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.

Back to Top