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Wyszukujesz frazę ""United States Food and Drug Administration"" wg kryterium: Temat


Tytuł :
Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed.
Autorzy :
Pregelj L; School of Chemistry and Molecular Biosciences, University of Queensland Business School, The University of Queensland, St Lucia, Queensland, Australia.
Hine DC; Kemmy Business School, University of Limerick, Limerick, Ireland.
Kesselheim AS; Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Darrow JJ; Program On Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.; Department of Law and Taxation, Bentley University, Waltham, Massachusetts, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Oct; Vol. 110 (4), pp. 1018-1024. Date of Electronic Publication: 2021 Jul 01.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Clinical Trials as Topic*
Drug Approval*
Drug Development*
United States Food and Drug Administration*
Drug and Narcotic Control ; Humans ; Time Factors ; United States
Czasopismo naukowe
Tytuł :
The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.
Autorzy :
Miller DL; Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring, MD, USA.
Kakar S; Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring, MD, USA.
Jiang L; Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring, MD, USA.
Spelic DC; Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring, MD, USA.
Burk L; Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring, MD, USA.
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Źródło :
The British journal of radiology [Br J Radiol] 2021 Oct 01; Vol. 94 (1126), pp. 20210373. Date of Electronic Publication: 2021 May 14.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Radiation Dosage*
United States Food and Drug Administration*
Diagnostic Imaging/*instrumentation
Diagnostic Imaging/*standards
Equipment Safety/*standards
Radiation Protection/*standards
Device Approval/legislation & jurisprudence ; Device Approval/standards ; Humans ; Radiation Protection/legislation & jurisprudence ; United States ; X-Rays
Czasopismo naukowe
Tytuł :
A contentious FDA ruling for Alzheimer's disease.
Autorzy :
The Lancet Neurology
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Źródło :
The Lancet. Neurology [Lancet Neurol] 2021 Aug; Vol. 20 (8), pp. 585. Date of Electronic Publication: 2021 Jul 05.
Typ publikacji :
Editorial
MeSH Terms :
Drug Approval*
United States Food and Drug Administration*
Alzheimer Disease/*drug therapy
Antibodies, Monoclonal/*therapeutic use
Antibodies, Monoclonal, Humanized/*therapeutic use
Amyloid/drug effects ; Humans ; United States
Opinia redakcyjna
Tytuł :
Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.
Autorzy :
Sahre MD; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Milligan L; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Graham RA; Theravance Biopharma US, Inc., South San Francisco, California, USA.
Reynolds KS; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Terzic A; Center for Regenerative Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Benjamin J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Burckart GJ; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Huang SM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Schuck R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Thompson AM; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Zineh I; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Aug; Vol. 110 (2), pp. 285-288. Date of Electronic Publication: 2021 Feb 16.
Typ publikacji :
Journal Article
MeSH Terms :
Advisory Committees/*organization & administration
Clinical Trials as Topic/*organization & administration
Kidney Diseases/*metabolism
Pharmacology, Clinical/*organization & administration
United States Food and Drug Administration/*organization & administration
Advisory Committees/standards ; Area Under Curve ; Clinical Trials as Topic/standards ; Drug Dosage Calculations ; Half-Life ; Kidney Diseases/epidemiology ; Multiple Chronic Conditions/epidemiology ; Pharmacology, Clinical/standards ; United States ; United States Food and Drug Administration/standards
Czasopismo naukowe
Tytuł :
A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System.
Autorzy :
Cocoros NM; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Fuller CC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Adimadhyam S; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Ball R; US Food and Drug Administration, Silver Spring, Maryland, USA.
Brown JS; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Dal Pan GJ; US Food and Drug Administration, Silver Spring, Maryland, USA.
Kluberg SA; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Lo Re V 3rd; Division of Infectious Diseases, Department of Medicine, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Maro JC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Nguyen M; US Food and Drug Administration, Silver Spring, Maryland, USA.
Orr R; US Food and Drug Administration, Silver Spring, Maryland, USA.
Paraoan D; US Food and Drug Administration, Silver Spring, Maryland, USA.
Perlin J; HCA Healthcare, Nashville, Tennessee, USA.
Poland RE; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.; HCA Healthcare, Nashville, Tennessee, USA.
Driscoll MR; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Sands K; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.; HCA Healthcare, Nashville, Tennessee, USA.
Toh S; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Yih WK; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Platt R; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
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Corporate Authors :
And the FDA-Sentinel COVID-19 Working Group
Źródło :
Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2021 Jul; Vol. 30 (7), pp. 827-837. Date of Electronic Publication: 2021 Apr 18.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Review
MeSH Terms :
COVID-19/*therapy
Health Information Management/*organization & administration
Product Surveillance, Postmarketing/*methods
Public Health Surveillance/*methods
United States Food and Drug Administration/*organization & administration
Antiviral Agents/therapeutic use ; COVID-19/epidemiology ; COVID-19/virology ; COVID-19 Vaccines/administration & dosage ; COVID-19 Vaccines/adverse effects ; Communicable Disease Control/legislation & jurisprudence ; Databases, Factual/statistics & numerical data ; Electronic Health Records/statistics & numerical data ; Health Policy ; Humans ; Pandemics/prevention & control ; Pandemics/statistics & numerical data ; United States/epidemiology ; United States Food and Drug Administration/legislation & jurisprudence
Czasopismo naukowe
Tytuł :
Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic.
Autorzy :
Maxwell K
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Źródło :
American journal of law & medicine [Am J Law Med] 2021 Jul; Vol. 47 (2-3), pp. 291-326.
Typ publikacji :
Journal Article
MeSH Terms :
Government Regulation*
United States Food and Drug Administration*
Device Approval/*legislation & jurisprudence
Medical Device Legislation/*standards
COVID-19/prevention & control ; Humans ; United States
Czasopismo naukowe
Tytuł :
Prescription medications for use in pregnancy-perspective from the US Food and Drug Administration.
Autorzy :
Wesley BD; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD. Electronic address: .
Sewell CA; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Chang CY; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Hatfield KP; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
Nguyen CP; Division of Urology, Obstetrics & Gynecology, US Food and Drug Administration, Silver Spring, MD.
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Źródło :
American journal of obstetrics and gynecology [Am J Obstet Gynecol] 2021 Jul; Vol. 225 (1), pp. 21-32.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*/legislation & jurisprudence
Drug Approval*/statistics & numerical data
Pregnancy*
Prescription Drugs*
United States Food and Drug Administration*
Animals ; Clinical Trials as Topic ; Female ; Fetus/drug effects ; Humans ; Lactation ; Pregnancy Complications/drug therapy ; Risk Assessment ; Teratogens ; United States
Czasopismo naukowe
Tytuł :
An introduction to risk evaluation and mitigation strategies.
Autorzy :
Dohm J; Covington & Burling LLP, DC, United States.
Ji M; Covington & Burling LLP, DC, United States. Electronic address: .
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Źródło :
Contraception [Contraception] 2021 Jul; Vol. 104 (1), pp. 4-7. Date of Electronic Publication: 2021 Apr 24.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*
Risk Evaluation and Mitigation*
United States Food and Drug Administration*
Abortifacient Agents, Steroidal ; Drug and Narcotic Control ; Humans ; Mifepristone ; United States
Czasopismo naukowe
Tytuł :
[Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States].
Autorzy :
Zhang C; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Zhou L; Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
Wang Y; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Tian L; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Yu X; NationalInstitutes for Food and Drug Control, Beijing, 100050.
Ji X; National Center of Standards Evaluation, SAMR, Beijing, 100088. E-mail:.
Zhang H; NationalInstitutes for Food and Drug Control, Beijing, 100050.
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Źródło :
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation [Zhongguo Yi Liao Qi Xie Za Zhi] 2021 Jun 08; Vol. 45 (3), pp. 315-320.
Typ publikacji :
Journal Article
MeSH Terms :
United States Food and Drug Administration*
China ; United States
Czasopismo naukowe
Tytuł :
Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018.
Autorzy :
Akoh CC; Duke University Medical Center, Box 2887, Durham, NC 27710, United States. Electronic address: .
Chen J; Duke University Medical Center, Box 2887, Durham, NC 27710, United States.
Kadakia R; Duke University Medical Center, Box 2887, Durham, NC 27710, United States.
Park YU; Department of Orthopedic Surgery, Ajou University Hospital, Ajou University School of Medicine, Suwon, Gyeonggido, Republic of Korea.
Kim H; Department of Orthopedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.
Adams SB; Duke University Medical Center, Box 2887, Durham, NC 27710, United States.
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Źródło :
Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons [Foot Ankle Surg] 2021 Jun; Vol. 27 (4), pp. 381-388. Date of Electronic Publication: 2020 May 18.
Typ publikacji :
Journal Article
MeSH Terms :
Databases, Factual*
United States Food and Drug Administration*
Arthrodesis/*instrumentation
Arthroplasty, Replacement/*instrumentation
Hallux/*surgery
Hallux Rigidus/*surgery
Joint Prosthesis/*adverse effects
Metatarsophalangeal Joint/*surgery
Osteoarthritis/*surgery
Adult ; Aged ; Female ; Follow-Up Studies ; Humans ; Incidence ; Male ; Middle Aged ; Osteoarthritis/epidemiology ; Prosthesis Failure/etiology ; Prosthesis-Related Infections/etiology ; Treatment Outcome ; United States/epidemiology
Czasopismo naukowe
Tytuł :
"Dangling" Accelerated Approvals in Oncology.
Autorzy :
Beaver JA; From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
Pazdur R; From the Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.
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Źródło :
The New England journal of medicine [N Engl J Med] 2021 May 06; Vol. 384 (18), pp. e68. Date of Electronic Publication: 2021 Apr 21.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
United States Food and Drug Administration*
Antibodies, Monoclonal/*therapeutic use
Antineoplastic Agents/*therapeutic use
B7-H1 Antigen/*antagonists & inhibitors
Programmed Cell Death 1 Receptor/*antagonists & inhibitors
Clinical Trials as Topic ; Humans ; Medical Oncology ; United States
Czasopismo naukowe
Tytuł :
A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020.
Autorzy :
Kayki-Mutlu G; Department of Pharmacology, Faculty of Pharmacy, Ankara University, Ankara, Turkey.
Michel MC; Department of Pharmacology, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany. .
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Źródło :
Naunyn-Schmiedeberg's archives of pharmacology [Naunyn Schmiedebergs Arch Pharmacol] 2021 May; Vol. 394 (5), pp. 839-852. Date of Electronic Publication: 2021 Apr 16.
Typ publikacji :
Journal Article; Review
MeSH Terms :
COVID-19*
Drug Approval*
Pandemics*
United States Food and Drug Administration*
Pharmacology, Clinical/*trends
Animals ; Drug Discovery ; Humans ; United States
Czasopismo naukowe
Tytuł :
How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals.
Autorzy :
Wu E; Department of Electrical Engineering, Stanford University, Stanford, CA, USA.
Wu K; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.
Daneshjou R; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.; Department of Dermatology, Stanford University, Stanford, CA, USA.
Ouyang D; Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Ho DE; Stanford Law School, Stanford University, Stanford, CA, USA.
Zou J; Department of Electrical Engineering, Stanford University, Stanford, CA, USA. .; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA. .; Chan-Zuckerberg Biohub, San Francisco, CA, USA. .
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Źródło :
Nature medicine [Nat Med] 2021 Apr; Vol. 27 (4), pp. 582-584.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
MeSH Terms :
Artificial Intelligence*
Device Approval*
Equipment and Supplies*
United States Food and Drug Administration*
Algorithms ; Databases as Topic ; Humans ; United States
Czasopismo naukowe
Tytuł :
Model-Informed Drug Development for Anti-Infectives: State of the Art and Future.
Autorzy :
Rayner CR; Certara, Princeton, New Jersey, USA.; Monash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.
Smith PF; Certara, Princeton, New Jersey, USA.
Andes D; University of Wisconsin-Madison, Madison, Wisconsin, USA.
Andrews K; Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Derendorf H; University of Florida, Gainesville, Florida, USA.
Friberg LE; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Hanna D; Bill & Melinda Gates Foundation, Seattle, Washington, USA.
Lepak A; University of Wisconsin-Madison, Madison, Wisconsin, USA.
Mills E; McMaster University, Hamilton, Ontario, Canada.
Polasek TM; Certara, Princeton, New Jersey, USA.; Centre for Medicines Use and Safety, Monash University, Melbourne, Victoria, Australia.; Department of Clinical Pharmacology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Roberts JA; Faculty of Medicine, University of Queensland Centre for Clinical Research, The University of Queensland, Brisbane, Queensland, Australia.; Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.; Division of Anaesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier, Montpellier, France.
Schuck V; Certara, Princeton, New Jersey, USA.
Shelton MJ; Certara, Princeton, New Jersey, USA.
Wesche D; Certara, Princeton, New Jersey, USA.
Rowland-Yeo K; Certara, Princeton, New Jersey, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Apr; Vol. 109 (4), pp. 867-891. Date of Electronic Publication: 2021 Mar 09.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Models, Biological*
Anti-Infective Agents/*pharmacology
Drug Development/*organization & administration
United States Food and Drug Administration/*organization & administration
Anti-Bacterial Agents/pharmacology ; Anti-Infective Agents/pharmacokinetics ; Antifungal Agents/pharmacology ; Antimalarials/pharmacology ; Antitubercular Agents/pharmacology ; Antiviral Agents/pharmacology ; Body Weight ; Dose-Response Relationship, Drug ; Drug Approval/organization & administration ; Drug Discovery/organization & administration ; Drug Resistance, Microbial/drug effects ; Drug Resistance, Microbial/physiology ; Humans ; Immunity/physiology ; Ivermectin/therapeutic use ; Kidney Function Tests ; Liver Function Tests ; Microbial Sensitivity Tests ; Onchocerciasis, Ocular/drug therapy ; Pediatrics ; Research Design ; United States ; United States Food and Drug Administration/standards
Czasopismo naukowe

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