المؤلفون: 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.

المصدر: 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.

نوع المنشور: Journal Article

بيانات الدورية: 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

مواضيع طبية MeSH: Antifungal Agents*/therapeutic use , Antifungal Agents*/administration & dosage , United States Food and Drug Administration* , Drug Development*, Humans ; Administration, Inhalation ; United States ; Aspergillosis, Allergic Bronchopulmonary/drug therapy ; Clinical Trials as Topic

المؤلفون: Borders-Hemphill V; Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22 room 4424, Silver Spring, MD, 20993, USA. Vicky.Borders-Hemphill@fda.hhs.gov., Chan IZ; Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22 room 4424, Silver Spring, MD, 20993, USA., Brown K; Purdue University, Indianapolis, IN, USA., Rider B; Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22 room 4424, Silver Spring, MD, 20993, USA., Taylor K; Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22 room 4424, Silver Spring, MD, 20993, USA., Chai G; Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22 room 4424, Silver Spring, MD, 20993, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2018 Mar; Vol. 52 (2), pp. 256-260. Date of Electronic Publication: 2017 Aug 07.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Drug Prescriptions* , Drugs, Generic* , Practice Patterns, Physicians'* , Terminology as Topic*, Drug Approval ; Humans ; Physicians ; United States ; United States Food and Drug Administration

المؤلفون: Shah MB; 1 Food and Drug Administration, Center for Drug Evaluation and Research/Office of Surveillance and Epidemiology/Office of Medication Error Prevention and Risk Management/Division of Medication Error Prevention and Analysis, Silver Spring, MD, USA., Merchant L; 1 Food and Drug Administration, Center for Drug Evaluation and Research/Office of Surveillance and Epidemiology/Office of Medication Error Prevention and Risk Management/Division of Medication Error Prevention and Analysis, Silver Spring, MD, USA., Chan IZ; 1 Food and Drug Administration, Center for Drug Evaluation and Research/Office of Surveillance and Epidemiology/Office of Medication Error Prevention and Risk Management/Division of Medication Error Prevention and Analysis, Silver Spring, MD, USA., Taylor K; 1 Food and Drug Administration, Center for Drug Evaluation and Research/Office of Surveillance and Epidemiology/Office of Medication Error Prevention and Risk Management/Division of Medication Error Prevention and Analysis, Silver Spring, MD, USA.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2017 Mar; Vol. 51 (2), pp. 232-236. Date of Electronic Publication: 2016 Sep 27.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: PubMed not MEDLINE