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Food and Drug Administration Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development.

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Title: Food and Drug Administration Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development.
Authors: 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., 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., Needles M; 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., Bensman TJ; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., McMaster O; Division of Pharmacology/Toxicology for Infectious Diseases, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Smith T; 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., Blakely B; Division of ENT, Sleep, Respiratory, and Anesthesia, Office of Health Technology 1, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland, USA., Chan IZ; Division of Medication Error Prevention and Analysis, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Puthawala K; Division of Pulmonology, Allergy, and Critical Care, Office of Immunology and Inflammation, 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., Kim Y; Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Lim R; Division of Pulmonology, Allergy, and Critical Care, Office of Immunology and Inflammation, 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, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., St Clair C; Division of Clinical Outcome Assessment, Office of Drug Evaluation Science, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., 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., Moss RB; Department of Pediatrics, Lucile Packard Children's Hospital and Stanford Children's Health, Stanford University Medical Center, Palo Alto, California, USA., Botgros R; Office of Biological Health Threats and Vaccines Strategy, European Medicines Agency, Amsterdam, The Netherlands., Bazaz R; National Aspergillosis Centre, University of Manchester, Manchester, United Kingdom., Denning DW; Global Action Fund for Fungal Infections, The University of Manchester, Manchester, United Kingdom., Marr KA; Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA., Husain S; Transplant Infectious Diseases Clinic, University Health Network, University of Toronto, Toronto, Ontario, Canada., Berman L; Pulmocide, London, United Kingdom., Christensen DJ; TFF Pharmaceuticals, Fort Worth, Texas, USA., Keywood C; Zambon SpA, Milan, Italy., Clayton RG; Aeremedea LLC, Fenandina Beach, Florida, USA., Walsh TJ; Transplantation-Oncology Infectious Diseases Program, Weill Cornell Medicine, New York, New York, USA.; Save Our Sick Kids Foundation, NewYork, New York, USA., Song HSE; 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.
Source: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2024 Jun 14; Vol. 78 (6), pp. 1564-1570.
Publication Type: Journal Article; Research Support, U.S. Gov't, Non-P.H.S.
Journal Info: Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Food and Drug Administration Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development.
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  Data: <searchLink fieldCode="AU" term="%22Jjingo+CJ%22">Jjingo CJ</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Bala+S%22">Bala S</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Waack+U%22">Waack U</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Needles+M%22">Needles M</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Bensman+TJ%22">Bensman TJ</searchLink>; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22McMaster+O%22">McMaster O</searchLink>; Division of Pharmacology/Toxicology for Infectious Diseases, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Smith+T%22">Smith T</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Blakely+B%22">Blakely B</searchLink>; Division of ENT, Sleep, Respiratory, and Anesthesia, Office of Health Technology 1, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Chan+IZ%22">Chan IZ</searchLink>; Division of Medication Error Prevention and Analysis, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Puthawala+K%22">Puthawala K</searchLink>; Division of Pulmonology, Allergy, and Critical Care, Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Dixon+C%22">Dixon C</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Kim+Y%22">Kim Y</searchLink>; Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Lim+R%22">Lim R</searchLink>; Division of Pulmonology, Allergy, and Critical Care, Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Colangelo+P%22">Colangelo P</searchLink>; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22St+Clair+C%22">St Clair C</searchLink>; Division of Clinical Outcome Assessment, Office of Drug Evaluation Science, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Nambiar+S%22">Nambiar S</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Moss+RB%22">Moss RB</searchLink>; Department of Pediatrics, Lucile Packard Children's Hospital and Stanford Children's Health, Stanford University Medical Center, Palo Alto, California, USA.<br /><searchLink fieldCode="AU" term="%22Botgros+R%22">Botgros R</searchLink>; Office of Biological Health Threats and Vaccines Strategy, European Medicines Agency, Amsterdam, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Bazaz+R%22">Bazaz R</searchLink>; National Aspergillosis Centre, University of Manchester, Manchester, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Denning+DW%22">Denning DW</searchLink>; Global Action Fund for Fungal Infections, The University of Manchester, Manchester, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Marr+KA%22">Marr KA</searchLink>; Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Husain+S%22">Husain S</searchLink>; Transplant Infectious Diseases Clinic, University Health Network, University of Toronto, Toronto, Ontario, Canada.<br /><searchLink fieldCode="AU" term="%22Berman+L%22">Berman L</searchLink>; Pulmocide, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Christensen+DJ%22">Christensen DJ</searchLink>; TFF Pharmaceuticals, Fort Worth, Texas, USA.<br /><searchLink fieldCode="AU" term="%22Keywood+C%22">Keywood C</searchLink>; Zambon SpA, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Clayton+RG%22">Clayton RG</searchLink>; Aeremedea LLC, Fenandina Beach, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Walsh+TJ%22">Walsh TJ</searchLink>; Transplantation-Oncology Infectious Diseases Program, Weill Cornell Medicine, New York, New York, USA.; Save Our Sick Kids Foundation, NewYork, New York, USA.<br /><searchLink fieldCode="AU" term="%22Song+HSE%22">Song HSE</searchLink>; DRT Strategies, Arlington, Virginia, USA.<br /><searchLink fieldCode="AU" term="%22Shukla+SJ%22">Shukla SJ</searchLink>; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Farley+J%22">Farley J</searchLink>; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
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  Data: <searchLink fieldCode="JN" term="%229203213%22">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</searchLink> [Clin Infect Dis] 2024 Jun 14; Vol. 78 (6), pp. 1564-1570.
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