💊FDA Draft Guidance on Coccidioidomycosis Drug Development Available
Disseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Disseminated Coccidioidomycosis: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C.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).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance for developing drugs against disseminated coccidioidomycosis outlines FDA's regulatory expectations affecting drug development strategies and clinical trials. Businesses in the pharmaceutical sector must comply with these new guidelines for clinical trial design and reporting, influencing their operational costs and strategic planning.