{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T00:16:29Z","timestamp":1790381789265,"version":"4.1.0"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"11","funder":[{"DOI":"10.13039\/100000778","name":"US Department of Labor","doi-asserted-by":"publisher","award":["SH-99067-SH0"],"award-info":[{"award-number":["SH-99067-SH0"]}],"id":[{"id":"10.13039\/100000778","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000778","name":"US Department of Labor","doi-asserted-by":"publisher","award":["SH-99067-SH0"],"award-info":[{"award-number":["SH-99067-SH0"]}],"id":[{"id":"10.13039\/100000778","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000030","name":"Centers for Disease Control and Prevention","doi-asserted-by":"publisher","award":["NU50CK2020003659"],"award-info":[{"award-number":["NU50CK2020003659"]}],"id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Center for Drug Evaluation and Research"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,6,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Coccidioidomycosis is a fungal disease endemic to the southwestern United States, Mexico, and Central and South America. Prevalence rates are increasing steadily, and new endemic areas of Coccidioides are emerging. Standard treatment is often administered for months to decades, and intolerance to medications and treatment failures are common. No new treatments for coccidioidomycosis have been approved in the United States in nearly 40 years. On 5 August 2020, the US Food and Drug Administration convened experts in coccidioidomycosis from academia, industry, patient groups, and other government agencies to discuss the disease landscape and strategies to facilitate product development for treatment of coccidioidomycosis. This article summarizes the key topics concerning drug development for coccidioidomycosis presented by speakers and panelists during the workshop, such as unmet need, trial designs, endpoints, incentives, research and development support, and collaborations to facilitate antifungal drug development.<\/jats:p>","DOI":"10.1093\/cid\/ciab904","type":"journal-article","created":{"date-parts":[[2021,10,13]],"date-time":"2021-10-13T04:38:46Z","timestamp":1634099926000},"page":"2061-2066","source":"Crossref","is-referenced-by-count":8,"title":["FDA Public Workshop Summary\u2014Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal Drugs"],"prefix":"10.1093","volume":"74","author":[{"given":"Elizabeth","family":"O\u2019Shaughnessy","sequence":"first","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuliya","family":"Yasinskaya","sequence":"additional","affiliation":[{"name":"Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"Dixon","sequence":"additional","affiliation":[{"name":"Division of Biometrics IV, Office of Translational Sciences, CDER, FDA , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Higgins","sequence":"additional","affiliation":[{"name":"Division of Biometrics IV, Office of Translational Sciences, CDER, FDA , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Moore","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, CDER, FDA , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kellie","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, CDER, FDA , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil M","family":"Ampel","sequence":"additional","affiliation":[{"name":"Valley Fever Center for Excellence, University of Arizona , Tucson, Arizona , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Angulo","sequence":"additional","affiliation":[{"name":"SCYNEXIS, Inc. , Jersey City, New Jersey , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janis E","family":"Blair","sequence":"additional","affiliation":[{"name":"Mayo Clinic , Phoenix, Arizona , 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Solutions , Inc., Tucson, Arizona , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gareth","family":"Lewis","sequence":"additional","affiliation":[{"name":"Mayne Pharma , Raleigh, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob","family":"Purdie","sequence":"additional","affiliation":[{"name":"Valley Fever Institute, Kern Medical , Bakersfield, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John H","family":"Rex","sequence":"additional","affiliation":[{"name":"F2G, Ltd. , Manchester , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa F","family":"Shubitz","sequence":"additional","affiliation":[{"name":"Valley Fever Center for Excellence, University of Arizona , Tucson, Arizona , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Stevens","sequence":"additional","affiliation":[{"name":"California Institute for Medical Research, San Jose, California, and Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine , Stanford, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen J","family":"Page","sequence":"additional","affiliation":[{"name":"DRT Strategies, Inc. , Arlington, Virginia , USA and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunita J","family":"Shukla","sequence":"additional","affiliation":[{"name":"Office of Infectious Diseases, Office of New Drugs, CDER, FDA , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John J","family":"Farley","sequence":"additional","affiliation":[{"name":"Office of Infectious Diseases, Office of New Drugs, CDER, FDA , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumathi","family":"Nambiar","sequence":"additional","affiliation":[{"name":"Division of 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