Food and Drug Administration Public Workshop Summary—Development Considerations of Antifungal Drugs to Address Unmet Medical Need Article Swipe
Yuliya Yasinskaya
,
Shukal Bala
,
Ursula Waack
,
Cheryl Dixon
,
Karen Higgins
,
Jason N. Moore
,
Caroline J Jjingo
,
Elizabeth O’Shaughnessy
,
Philip Colangelo
,
Radu Botgros
,
Sumathi Nambiar
,
David Angulo
,
Aaron Dane
,
Tom Chiller
,
Michael R. Hodges
,
Taylor Sandison
,
William Hope
,
Thomas J. Walsh
,
Peter Pappas
,
Aspasia Katragkou
,
Laura Kovanda
,
John Rex
,
Kieren A. Marr
,
Luis Ostrosky‐Zeichner
,
Shohko Sekine
,
Monika Deshpande
,
Sunita J. Shukla
,
John Farley
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/cid/ciad195
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/cid/ciad195
Pressing challenges in the treatment of invasive fungal infections (IFIs) include emerging and rare pathogens, resistant/refractory infections, and antifungal armamentarium limited by toxicity, drug-drug interactions, and lack of oral formulations. Development of new antifungal drugs is hampered by the limitations of the available diagnostics, clinical trial endpoints, prolonged trial duration, difficulties in patient recruitment, including subpopulations (eg, pediatrics), and heterogeneity of the IFIs. On 4 August 2020, the US Food and Drug Administration convened a workshop that included IFI experts from academia, industry, and other government agencies to discuss the IFI landscape, unmet need, and potential strategies to facilitate the development of antifungal drugs for treatment and prophylaxis. This article summarizes the key topics presented and discussed during the workshop, such as incentives and research support for drug developers, nonclinical development, clinical trial design challenges, lessons learned from industry, and potential collaborations to facilitate antifungal drug development.
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Metadata
- Type
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- Language
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- Landing Page
- https://doi.org/10.1093/cid/ciad195
- https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad195/49781239/ciad195.pdf
- OA Status
- hybrid
- Cited By
- 7
- References
- 30
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4362657839
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4362657839Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1093/cid/ciad195Digital Object Identifier
- Title
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Food and Drug Administration Public Workshop Summary—Development Considerations of Antifungal Drugs to Address Unmet Medical NeedWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-04-06Full publication date if available
- Authors
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Yuliya Yasinskaya, Shukal Bala, Ursula Waack, Cheryl Dixon, Karen Higgins, Jason N. Moore, Caroline J Jjingo, Elizabeth O’Shaughnessy, Philip Colangelo, Radu Botgros, Sumathi Nambiar, David Angulo, Aaron Dane, Tom Chiller, Michael R. Hodges, Taylor Sandison, William Hope, Thomas J. Walsh, Peter Pappas, Aspasia Katragkou, Laura Kovanda, John Rex, Kieren A. Marr, Luis Ostrosky‐Zeichner, Shohko Sekine, Monika Deshpande, Sunita J. Shukla, John FarleyList of authors in order
- Landing page
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https://doi.org/10.1093/cid/ciad195Publisher landing page
- PDF URL
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https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad195/49781239/ciad195.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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hybridOpen access status per OpenAlex
- OA URL
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https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad195/49781239/ciad195.pdfDirect OA link when available
- Concepts
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Medicine, Antifungal, Clinical trial, Drug development, Drug, Intensive care medicine, Food and drug administration, Antifungal drug, Government (linguistics), Pharmacology, Pathology, Linguistics, Dermatology, PhilosophyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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7Total citation count in OpenAlex
- Citations by year (recent)
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2025: 3, 2024: 4Per-year citation counts (last 5 years)
- References (count)
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30Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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