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Food and Drug Administration Public Workshop Summary-Development Considerations of Antifungal Drugs to Address Unmet Medical Need.
Yasinskaya, Yuliya; Bala, Shukal; Waack, Ursula; Dixon, Cheryl; Higgins, Karen; Moore, Jason N; Jjingo, Caroline J; O'Shaughnessy, Elizabeth; Colangelo, Philip; Botgros, Radu; Nambiar, Sumathi; Angulo, David; Dane, Aaron; Chiller, Tom; Hodges, Michael R; Sandison, Taylor; Hope, William; Walsh, Thomas J; Pappas, Peter; Katragkou, Aspasia; Kovanda, Laura; Rex, John H; Marr, Kieren A; Ostrosky-Zeichner, Luis; Sekine, Shohko; Deshpande, Monika; Shukla, Sunita J; Farley, John.
Affiliation
  • Yasinskaya Y; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bala S; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Waack U; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Dixon C; Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland, USA.
  • Higgins K; Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland, USA.
  • Moore JN; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland, USA.
  • Jjingo CJ; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • O'Shaughnessy E; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Colangelo P; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration ; Silver Spring, Maryland, USA.
  • Botgros R; Health Threats and Vaccines Strategy, European Medicines Agency, Amsterdam, the Netherlands.
  • Nambiar S; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Angulo D; Scynexis, Jersey City, New Jersey, USA.
  • Dane A; DaneStat Consulting, Macclesfield, United Kingdom.
  • Chiller T; Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
  • Hodges MR; RNA Medicines, San Diego, California, USA.
  • Sandison T; Cidara Therapeutics, San Diego, California, USA.
  • Hope W; Centre for Excellence in Infectious Diseases Research, Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
  • Walsh TJ; Transplantation-Oncology Infectious Diseases Program, Weill Cornell Medicine, New York, New York, USA.
  • Pappas P; Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA.
  • Katragkou A; Transplantation-Oncology Infectious Disease Program, Weill Cornell Medicine, New York, New York, USA.
  • Kovanda L; Astellas Pharma Global Development, Northbrook, Illinois, USA.
  • Rex JH; F2G, Manchester, United Kingdom.
  • Marr KA; Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
  • Ostrosky-Zeichner L; Director of the Laboratory of Mycology Research, McGovern Medical School, Houston, Texas, USA.
  • Sekine S; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Deshpande M; DRT Strategies, Arlington, Virginia, USA.
  • Shukla SJ; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Farley J; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Infect Dis ; 77(3): 380-387, 2023 08 14.
Article in En | MEDLINE | ID: mdl-37021650
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Invasive Fungal Infections / Mycoses Type of study: Clinical_trials Limits: Child / Humans Country/Region as subject: America do norte Language: En Journal: Clin Infect Dis Journal subject: DOENCAS TRANSMISSIVEIS Year: 2023 Document type: Article Affiliation country: United States Country of publication: United States
Fulltext
Add to My VHL
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Invasive Fungal Infections / Mycoses Type of study: Clinical_trials Limits: Child / Humans Country/Region as subject: America do norte Language: En Journal: Clin Infect Dis Journal subject: DOENCAS TRANSMISSIVEIS Year: 2023 Document type: Article Affiliation country: United States Country of publication: United States