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# cIAI Drug Development Guidance
- URL: https://www.fdaweb.com/ciai-drug-development-guidance/
- Published: 2018-05-29T12:00:00.000Z
- Updated: 2026-09-15T00:08:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141553

FDA has issued a guidance, *Complicated Intra-Abdominal Infections: Developing Drugs for Treatment*, to assist sponsors in clinical development of drugs to treat complicated intra-abdominal infections (cIAI). The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321390.pdf?ref=fdaweb.com) specifically addresses the agency’s thinking on the overall development program and clinical trial designs for drugs to support an indication for treating cIAI. It does not contain certain discussion of the general issues of statistical analysis or clinical trial design covered in two International Conference on Harmonization guidances.