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


Tytuł :
Understanding Vaccine Safety and the Roles of the FDA and the CDC.
Autorzy :
Meissner HC; From the Department of Pediatrics, Tufts Children's Hospital, Tufts Medical Center, Boston.
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Źródło :
The New England journal of medicine [N Engl J Med] 2022 Apr 28; Vol. 386 (17), pp. 1638-1645.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Adverse Drug Reaction Reporting Systems*
Centers for Disease Control and Prevention, U.S.*
United States Food and Drug Administration*
Vaccines*/adverse effects
Humans ; United States
Czasopismo naukowe
Tytuł :
FDA Indication Extrapolations-Allowing Flexibility While Providing Greater Clarity.
Autorzy :
Ramachandran R; National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Veterans Affairs Connecticut Healthcare System and Yale University, West Haven, Connecticut.
Ross JS; National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut.
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Źródło :
JAMA network open [JAMA Netw Open] 2022 Apr 01; Vol. 5 (4), pp. e227961. Date of Electronic Publication: 2022 Apr 01.
Typ publikacji :
Journal Article
MeSH Terms :
United States Food and Drug Administration*
Humans ; United States
Czasopismo naukowe
Tytuł :
Deadly Legacy-The 510(k) Path to Medical Device Clearance.
Autorzy :
Adashi EY; Brown University, Providence, Rhode Island.
Robison KM; Program in Women's Oncology, Brown University, Providence, Rhode Island.
Cohen IG; Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts.
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Źródło :
JAMA surgery [JAMA Surg] 2022 Mar 01; Vol. 157 (3), pp. 185-186.
Typ publikacji :
Journal Article
MeSH Terms :
United States Food and Drug Administration*
Humans ; United States
Czasopismo naukowe
Tytuł :
The Pharmaceutical Industry in 2021. An Analysis of FDA Drug Approvals from the Perspective of Molecules.
Autorzy :
de la Torre BG; KRISP, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa.
Albericio F; School of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South Africa.; Institute for Advanced Chemistry of Catalonia (IQAC-CSIC), 08034 Barcelona, Spain.; CIBER-BBN, Networking Centre on Bioengineering, Biomaterials and Nanomedicine, Department of Organic Chemistry, University of Barcelona, 08028 Barcelona, Spain.
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Źródło :
Molecules (Basel, Switzerland) [Molecules] 2022 Feb 05; Vol. 27 (3). Date of Electronic Publication: 2022 Feb 05.
Typ publikacji :
Historical Article; Journal Article; Review
MeSH Terms :
Drug Approval*/history
Drug Approval*/statistics & numerical data
Drug Industry*/history
United States Food and Drug Administration*
Biological Products ; History, 21st Century ; Humans ; United States
Czasopismo naukowe
Tytuł :
Assessment of Public Opinion on Transparency at the US Food and Drug Administration.
Autorzy :
Azad TD; Department of Neurosurgery, Johns Hopkins Hospital, Baltimore, Maryland.
Plott CF; Johns Hopkins School of Medicine, Baltimore, Maryland.
Gielen AC; Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Sharfstein JM; Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
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Źródło :
JAMA network open [JAMA Netw Open] 2022 Feb 01; Vol. 5 (2), pp. e220026. Date of Electronic Publication: 2022 Feb 01.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Drug Approval*
Public Opinion*
United States Food and Drug Administration*
Adult ; Aged ; Cross-Sectional Studies ; Female ; Humans ; Male ; Middle Aged ; United States/epidemiology
Czasopismo naukowe
Tytuł :
Regulation of Dietary Supplements and Nutraceutical Products in the United States: An Argument for Greater Oversight and Uniform Standards.
Autorzy :
Grundmann O
Kumar P
Rogge M
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Corporate Authors :
ACCP Public Policy Committee
Źródło :
Journal of clinical pharmacology [J Clin Pharmacol] 2022 Jan; Vol. 62 (1), pp. 14-16. Date of Electronic Publication: 2021 Nov 30.
Typ publikacji :
Journal Article
MeSH Terms :
Dietary Supplements/*standards
United States Food and Drug Administration/*organization & administration
Dietary Supplements/adverse effects ; Humans ; United States ; United States Food and Drug Administration/standards
Czasopismo naukowe
Tytuł :
Product Approval and Public Health at the US Food and Drug Administration.
Autorzy :
Lurie P; Center for Science in the Public Interest, Washington, DC.
Sharfstein JM; Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
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Źródło :
JAMA [JAMA] 2021 Dec 28; Vol. 326 (24), pp. 2469-2470.
Typ publikacji :
Historical Article; Journal Article
MeSH Terms :
Drug Approval*/history
Drug Approval*/legislation & jurisprudence
Public Health*
United States Food and Drug Administration*
Analgesics, Opioid/history ; Animals ; Consumer Product Safety ; Government Regulation ; History, 21st Century ; Humans ; United States
Czasopismo naukowe
Tytuł :
Assessment of FDA-approved drugs against Strongyloides ratti in vitro and in vivo to identify potentially active drugs against strongyloidiasis.
Autorzy :
Keiser J; Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Socinstrasse 57, 4051, Basel, Switzerland. .; University of Basel, 4003, Basel, Switzerland. .
Häberli C; Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Socinstrasse 57, 4051, Basel, Switzerland.; University of Basel, 4003, Basel, Switzerland.
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Źródło :
Parasites & vectors [Parasit Vectors] 2021 Dec 23; Vol. 14 (1), pp. 615. Date of Electronic Publication: 2021 Dec 23.
Typ publikacji :
Journal Article; Randomized Controlled Trial, Veterinary
MeSH Terms :
United States Food and Drug Administration*
Anthelmintics/*pharmacology
Rodent Diseases/*parasitology
Strongyloides ratti/*drug effects
Strongyloidiasis/*veterinary
Animals ; Laboratory Animal Science ; Rats ; Rodent Diseases/drug therapy ; Strongyloidiasis/drug therapy ; Strongyloidiasis/parasitology ; United States
Czasopismo naukowe
Tytuł :
Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action.
Autorzy :
Olivier T; Department of Oncology, Geneva University Hospital, Geneva, Switzerland.
Haslam A; Department of Epidemiology and Biostatistics, University of California, San Francisco.
Prasad V; Department of Epidemiology and Biostatistics, University of California, San Francisco.
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Źródło :
JAMA network open [JAMA Netw Open] 2021 Dec 01; Vol. 4 (12), pp. e2138793. Date of Electronic Publication: 2021 Dec 01.
Typ publikacji :
Journal Article; Observational Study; Research Support, Non-U.S. Gov't
MeSH Terms :
United States Food and Drug Administration*
Antineoplastic Agents/*pharmacology
Drug Approval/*statistics & numerical data
Antineoplastic Agents/classification ; Antineoplastic Agents/standards ; Cross-Sectional Studies ; Drug Approval/methods ; Humans ; Retrospective Studies ; United States
Czasopismo naukowe
Tytuł :
The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes.
Autorzy :
Cherkaoui S; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Pinnow E; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Bulatao I; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Day B; University of Maryland School of Medicine, University of Maryland, Baltimore, Maryland, USA.
Kalaria M; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Brajovic S; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Dal Pan G; Office of Surveillance and Epidemiology, 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 Dec; Vol. 110 (6), pp. 1512-1525. Date of Electronic Publication: 2021 Jul 08.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
United States Food and Drug Administration*/standards
Biological Products/*administration & dosage
Drug Approval/*methods
Drug Development/*methods
Product Surveillance, Postmarketing/*methods
Biological Products/standards ; Cohort Studies ; Drug Development/standards ; Humans ; Product Surveillance, Postmarketing/standards ; Retrospective Studies ; Treatment Outcome ; United States/epidemiology
Czasopismo naukowe
Tytuł :
Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices: A Landscape Assessment.
Autorzy :
Timbie JW; RAND Corporation, Arlington, VA, USA. Electronic address: .
Kim AY; RAND Corporation, Santa Monica, CA, USA.
Concannon TW; RAND Corporation, Boston, MA, USA.
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Źródło :
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [Value Health] 2021 Dec; Vol. 24 (12), pp. 1792-1798. Date of Electronic Publication: 2021 Aug 18.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Device Approval*
Technology Assessment, Biomedical*
United States Food and Drug Administration*
Interviews as Topic ; United States
Czasopismo naukowe
Tytuł :
The Current State of Pharma and the FDA: Approval of a Dementia Drug as a Case in Point.
Autorzy :
Eiser AR; Adjunct Senior Fellow, Leonard Davis Institute, Adjunct Fellow, Center for Public Health Initiatives, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Electronic address: .
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Źródło :
The American journal of medicine [Am J Med] 2021 Dec; Vol. 134 (12), pp. 1442-1443. Date of Electronic Publication: 2021 Jul 12.
Typ publikacji :
Editorial
MeSH Terms :
Drug Industry*
United States Food and Drug Administration*
Alzheimer Disease/*drug therapy
Antibodies, Monoclonal, Humanized/*therapeutic use
Advisory Committees ; Cost-Benefit Analysis ; Drug Approval ; Drug Costs ; Drug Development ; Humans ; United States
Opinia redakcyjna
Tytuł :
Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval.
Autorzy :
Shahzad M; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Naci H; Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
Wagner AK; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
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Źródło :
JAMA internal medicine [JAMA Intern Med] 2021 Dec 01; Vol. 181 (12), pp. 1673-1675.
Typ publikacji :
Journal Article
MeSH Terms :
United States Food and Drug Administration*
Drug Approval/*legislation & jurisprudence
Medicare/*economics
Neoplasms/*drug therapy
Drug Approval/economics ; Follow-Up Studies ; Humans ; Neoplasms/economics ; Retrospective Studies ; United States
Czasopismo naukowe
Tytuł :
[Research on Supervision System of Combination Product in FDA].
Autorzy :
Dong Q; National Institutes for Food and Drug Control, Beijing, 102629.
Tian M; Beijing Northern Hospital of Weaponry Industry, Beijing, 100089.
Mu R; National Institutes for Food and Drug Control, Beijing, 102629.
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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 Nov 30; Vol. 45 (6), pp. 670-673.
Typ publikacji :
Journal Article
MeSH Terms :
United States Food and Drug Administration*
Device Approval ; Drug Approval ; United States
Czasopismo naukowe
Tytuł :
Investigation of Factors Associated With Immunogenicity Labeling Updates and Characteristics of Biologics License Applications.
Autorzy :
Jiang AL; School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
Breder CD; Advanced Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC, USA.
Chang LC; School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Nov; Vol. 110 (5), pp. 1381-1388. Date of Electronic Publication: 2021 Aug 24.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Immunogenetic Phenomena*
Licensure, Pharmacy*/legislation & jurisprudence
United States Food and Drug Administration*/legislation & jurisprudence
Biological Products/*immunology
Drug Approval/*methods
Drug Labeling/*methods
Drug Approval/legislation & jurisprudence ; Drug Labeling/legislation & jurisprudence ; Humans ; United States
Czasopismo naukowe
Tytuł :
Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
Autorzy :
Galluppi GR; Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.
Brar S; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
Caro L; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Chen Y; Department of Drug Metabolism and Pharmacokinetics, Genentech Inc., a member of the Roche Group, South San Francisco, California, USA.
Frey N; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.
Grimm HP; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.
Rudd DJ; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Li CC; Department of Clinical Pharmacology, Genentech, member of the Roche group, South San Francisco, California, USA.
Magee M; GlaxoSmithKline, Philadelphia, Pennsylvania, USA.
Mukherjee A; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
Nagao L; Faegre Drinker Biddle & Reath, LLP, Washington, DC, USA.
Purohit VS; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
Roy A; Bristol Myers, Inc., Woodbury, Connecticut, USA.
Salem AH; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.; Ain Shams University, Cairo, Egypt.
Sinha V; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Suleiman AA; Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.
Taskar KS; DMPK, IVIVT, GlaxoSmithKline, Ware, UK.
Upreti VV; Clinical Pharmacology Modeling and Simulation, Amgen Inc., South San Francisco, California, USA.
Weber B; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Cook J; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
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Źródło :
Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Nov; Vol. 110 (5), pp. 1172-1175. Date of Electronic Publication: 2021 May 15.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Design*
United States Food and Drug Administration*/legislation & jurisprudence
Drug Approval/*methods
Drug Industry/*methods
Drug Approval/legislation & jurisprudence ; Drug Development/legislation & jurisprudence ; Drug Development/methods ; Drug Industry/legislation & jurisprudence ; Humans ; Pilot Projects ; United States
Czasopismo naukowe
Tytuł :
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.
Autorzy :
Lee J; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Gong Y; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Bhoopathy S; Absorption Systems, Exton, Pennsylvania, USA.
DiLiberti CE; Montclair Bioequivalence Services, LLC, Upper Montclair, New Jersey, USA.
Hooker AC; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Rostami-Hodjegan A; Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK.; Certara, Princeton, New Jersey, USA.
Schmidt S; Center for Pharmacometrics & Systems Pharmacology, Department of Pharmaceutics, University of Florida, Orlando, Florida, USA.
Suarez-Sharp S; Simulations Plus, Inc, Lancaster, California, USA.
Lukacova V; Simulations Plus, Inc, Lancaster, California, USA.
Fang L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, 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 Nov; Vol. 110 (5), pp. 1190-1195. Date of Electronic Publication: 2020 Dec 29.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, P.H.S.; Review
MeSH Terms :
Data Analysis*
Drugs, Generic*/standards
Research Report*
United States Food and Drug Administration*/statistics & numerical data
Drug and Narcotic Control/*methods
Education/*methods
Education/statistics & numerical data ; Humans ; Therapeutic Equivalency ; United States
Czasopismo naukowe
Tytuł :
Statins No Longer Contraindicated in Pregnancy.
Autorzy :
Aschenbrenner DS; Diane S. Aschenbrenner is a former member of the faculty at Notre Dame of Maryland University and the Johns Hopkins University School of Nursing. She coordinates Drug Watch: .
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Źródło :
The American journal of nursing [Am J Nurs] 2021 Nov 01; Vol. 121 (11), pp. 22.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
United States Food and Drug Administration*
Atorvastatin/*therapeutic use
Cardiovascular Diseases/*drug therapy
Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use
Pravastatin/*therapeutic use
Contraindications ; Female ; Humans ; Pregnancy ; United States
Czasopismo naukowe

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