Health and Human Services Department Docket FDA-2025-D-1308 Notice

2025-18002: Disseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Disseminated Coccidioidomycosis: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C. immitis and C. posadasii).

The agency’s own summary, as published.

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