GUIDANCE DOCUMENT
Crohn’s Disease: Developing Drugs for Treatment April 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2022-D-0091
- Docket Number:
- FDA-2022-D-0091
- Issued by:
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Guidance Issuing OfficeCenter for Drug 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Crohn’s Disease: Developing Drugs for Treatment.” This draft guidance addresses FDA’s current thinking about necessary attributes of clinical trials for developing drugs for the treatment of Crohn’s disease in adults, including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.