Docket Number: FDA-2025-D-1308 Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Disseminated Coccidioidomycosis: Developing Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C.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).
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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
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Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2025-D-1308.
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Content current as of:
09/16/2025
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