Health Law Daily Wrap Up, CLINICAL RESEARCH—FDA GUIDANCE NOTICES: Disseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, (Sep 18, 2025)
By WK Editorial Staff
The FDA has announced the availability of a draft guidance for industry entitled “Disseminated Coccidioidomycosis: Developing Drugs for Treatment.”
The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C.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) ( Notice , 90 Fed. Reg. 44827 (Sept. 17, 2025)).
Dates. Submit either electronic or written comments on the draft guidance by November 17, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
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