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Tytuł :
Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.
Autorzy :
Muehlematter UJ; Institute of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.
Daniore P; Institute of Law, University of Zurich, Switzerland.
Vokinger KN; Institute of Law, University of Zurich, Switzerland. Electronic address: .
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Źródło :
The Lancet. Digital health [Lancet Digit Health] 2021 Mar; Vol. 3 (3), pp. e195-e203. Date of Electronic Publication: 2021 Jan 18.
Typ publikacji :
Comparative Study; Journal Article; Review
MeSH Terms :
Artificial Intelligence*
Biomedical Technology*
Equipment and Supplies*
Government Regulation*
Machine Learning*
Databases, Factual ; Device Approval ; Europe ; Humans ; Radiology ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Standardizing output-based surveillance to control non-regulated cattle diseases: Aspiring for a single general regulatory framework in the European Union.
Autorzy :
Costa L; Polytechnic Institute of Portalegre, Praça do Município 11, 7300-110, Portalegre, Portugal. Electronic address: .
Duarte EL; MED- Mediterranean Institute for Agriculture, Environment and Development & Departamento de Medicina Veterinária, Universidade de Évora, Portugal.
Knific T; University of Ljubljana, Veterinary Faculty, Slovenia.
Hodnik JJ; University of Ljubljana, Veterinary Faculty, Slovenia.
van Roon A; University of Utrecht, the Netherlands.
Fourichon C; INRA- Institut National de la Recherche Agronomique & Oniris, BIOEPAR Nantes, France.
Koleci X; Faculty of Veterinary Medicine, Agricultural University of Tirana, Albania.
van Schaik G; University of Utrecht, the Netherlands; Royal GD, the Netherlands.
Gunn G; SRUC, North Faculty, Inverness, Scotland, IV2 5NA, UK.
Madouasse A; INRA- Institut National de la Recherche Agronomique & Oniris, BIOEPAR Nantes, France.
Berezowski J; Veterinary Public Health Institute, University of Bern, Switzerland.
Santman-Berends I; University of Utrecht, the Netherlands; Royal GD, the Netherlands.
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Źródło :
Preventive veterinary medicine [Prev Vet Med] 2020 Oct; Vol. 183, pp. 105130. Date of Electronic Publication: 2020 Aug 25.
Typ publikacji :
Journal Article
MeSH Terms :
European Union*
Government Regulation*
Cattle Diseases/*epidemiology
Epidemiological Monitoring/*veterinary
Animals ; Cattle ; Cattle Diseases/prevention & control ; Europe/epidemiology ; Population Surveillance/methods
Czasopismo naukowe
Tytuł :
Is there light at the end of the Covid-19 tunnel?
Autorzy :
Mortimer PP; Virus Reference Laboratory, Colindale, London, UK.
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Źródło :
Reviews in medical virology [Rev Med Virol] 2021 May; Vol. 31 (3), pp. e2173. Date of Electronic Publication: 2020 Oct 01.
Typ publikacji :
Editorial
MeSH Terms :
COVID-19/*prevention & control
COVID-19 Vaccines/*economics
Drug Industry/*economics
COVID-19/epidemiology ; COVID-19/immunology ; COVID-19/virology ; COVID-19 Vaccines/biosynthesis ; Costs and Cost Analysis ; Drug Approval ; Europe/epidemiology ; Financing, Government ; Government Regulation ; Health Services Accessibility/organization & administration ; Humans ; Mass Vaccination/economics ; Mass Vaccination/organization & administration ; Pandemics/prevention & control ; SARS-CoV-2/pathogenicity ; United States/epidemiology
Opinia redakcyjna
Tytuł :
CoViD-19 and psychiatry: can mental illness justify further exceptions to the obligation to stay at home?
Autorzy :
Montanari Vergallo G; Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, Sapienza University of Rome, Italy.
Bersani G; Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Italy.
Rinaldi R; Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, Sapienza University of Rome, Italy.
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Źródło :
Rivista di psichiatria [Riv Psichiatr] 2020 Jul-Aug; Vol. 55 (4), pp. 245-249.
Typ publikacji :
Journal Article
MeSH Terms :
Betacoronavirus*
Government Regulation*
Coronavirus Infections/*psychology
Mental Disorders/*psychology
Pneumonia, Viral/*psychology
Quarantine/*legislation & jurisprudence
COVID-19 ; Coronavirus Infections/complications ; Coronavirus Infections/diagnosis ; Emergencies ; Europe ; Health Services Needs and Demand ; Human Rights ; Humans ; Italy ; Mental Disorders/complications ; Pandemics ; Patient Compliance/psychology ; Pneumonia, Viral/complications ; Pneumonia, Viral/diagnosis ; SARS-CoV-2 ; Work
Czasopismo naukowe
Tytuł :
The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods.
Autorzy :
Krebs A; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.; Konstanz Research School Chemical Biology, University of Konstanz, 78457, Konstanz, Germany.
van Vugt-Lussenburg BMA; BioDetection Systems BV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Waldmann T; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.; trenzyme GmbH, Byk-Gulden-Str. 2, 78467, Konstanz, Germany.
Albrecht W; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Boei J; Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Ter Braak B; Division of Drug Discovery and Safety, Leiden Academic Center for Drug Research, Leiden University, Einsteinweg 55, 2333 CC, Leiden, The Netherlands.
Brajnik M; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
Braunbeck T; Aquatic Ecology and Toxicology Group, Center for Organismal Studies, University of Heidelberg, Im Neuenheimer Feld 504, 69120, Heidelberg, Germany.
Brecklinghaus T; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Busquet F; CAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
Dinnyes A; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Dokler J; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
Dolde X; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
Exner TE; Edelweiss Connect GmbH, Technology Park Basel, Hochbergerstrasse 60C, 4057, Basel, Switzerland.
Fisher C; Simcyp Division, Certara UK Limited, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.
Fluri D; InSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
Forsby A; Unit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.; Department of Biochemistry and Biophysics, Stockholm University, 10691, Stockholm, Sweden.
Hengstler JG; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Holzer AK; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.
Janstova Z; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Jennings P; Division of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
Kisitu J; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany.; Konstanz Research School Chemical Biology, University of Konstanz, 78457, Konstanz, Germany.
Kobolak J; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Kumar M; Department of Development and Regeneration, Stem Cell Biology and Embryology, Stem Cell Institute Leuven, KU Leuven, O&N IV Herestraat 49, 3000, Leuven, Belgium.
Limonciel A; Division of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
Lundqvist J; Unit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.; Department of Biochemistry and Biophysics, Stockholm University, 10691, Stockholm, Sweden.
Mihalik B; BioTalentum Ltd., Aulich Lajos str. 26, Gödöllő, 2100, Hungary.
Moritz W; InSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
Pallocca G; CAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
Ulloa APC; Unit of Toxicology Sciences, Swedish Toxicology Sciences Research Center (Swetox), Karolinska Institutet, Forskargatan 20, 151 36, Södertälje, Sweden.
Pastor M; Department of Experimental and Health Sciences, Research Programme on Biomedical Informatics (GRIB), Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Universitat Pompeu Fabra, 08003, Barcelona, Spain.
Rovida C; CAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany.
Sarkans U; European Molecular Biology Laboratory, European Bioinformatics Institute (EMBL-EBI), Wellcome Genome Campus, Cambridge, UK.
Schimming JP; Leiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
Schmidt BZ; Switch Laboratory, Department of Cellular and Molecular Medicine, VIB-KU Leuven Center for Brain and Disease Research, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
Stöber R; Leibniz-Institut für Arbeitsforschung an der TU Dortmund, Leibniz Research Center for Working Environment and Human Factors (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.
Strassfeld T; InSphero AG, Wagistrasse 27, 8952, Schlieren, Switzerland.
van de Water B; Leiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
Wilmes A; Division of Molecular and Computational Toxicology, Department of Chemistry and Pharmaceutical Sciences, Vrije Universiteit Amsterdam, De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
van der Burg B; BioDetection Systems BV, Science Park 406, 1098 XH, Amsterdam, The Netherlands.
Verfaillie CM; Department of Development and Regeneration, Stem Cell Biology and Embryology, Stem Cell Institute Leuven, KU Leuven, O&N IV Herestraat 49, 3000, Leuven, Belgium.
von Hellfeld R; Aquatic Ecology and Toxicology Group, Center for Organismal Studies, University of Heidelberg, Im Neuenheimer Feld 504, 69120, Heidelberg, Germany.
Vrieling H; Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Vrijenhoek NG; Leiden Academic Center for Drug Research, LACDR/Toxicology, Leiden University, PO Box 9500, 2300 RA, Leiden, The Netherlands.
Leist M; In Vitro Toxicology and Biomedicine, Department Inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Universitaetsstr. 10, 78457, Konstanz, Germany. .; CAAT Europe, University of Konstanz, Steinbeis SU-1866, 78457, Konstanz, Germany. .
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Źródło :
Archives of toxicology [Arch Toxicol] 2020 Jul; Vol. 94 (7), pp. 2435-2461. Date of Electronic Publication: 2020 Jul 06.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Documentation*
Government Regulation*
Toxicity Tests*
Electronic Data Processing/*legislation & jurisprudence
Toxicology/*legislation & jurisprudence
Animals ; Cells, Cultured ; Europe ; Humans ; Policy Making ; Reproducibility of Results ; Retrospective Studies ; Risk Assessment ; Terminology as Topic ; Zebrafish/embryology
Czasopismo naukowe
Tytuł :
Clinical evidence supporting the marketing authorization of biosimilars in Europe.
Autorzy :
Allocati E; Center for Health Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy. .
Bertele' V; Center for Health Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.
Gerardi C; Center for Health Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.
Garattini S; Center for Health Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.
Banzi R; Center for Health Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy.
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Źródło :
European journal of clinical pharmacology [Eur J Clin Pharmacol] 2020 Apr; Vol. 76 (4), pp. 557-566. Date of Electronic Publication: 2020 Jan 02.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Clinical Trials as Topic*/legislation & jurisprudence
Drug Approval*/economics
Drug Approval*/legislation & jurisprudence
Government Regulation*
Biosimilar Pharmaceuticals/*therapeutic use
Marketing/*legislation & jurisprudence
Biosimilar Pharmaceuticals/economics ; Databases, Factual ; Drug Industry ; Europe ; Humans ; Treatment Outcome
Czasopismo naukowe
Tytuł :
How Do Drug Regulatory Bodies Deal With Potential Innovative Therapies?
Autorzy :
Tutone M; Utrecht University, Utrecht, The Netherlands.
Villa F; Italian Medicines Agency (AIFA), Via del Tritone, 181-00187, Rome, Italy. .; Università degli Studi del Piemonte Orientale 'Amedeo Avogadro,' Department of Pharmaceutical Sciences, Novara, Italy. .
Addis A; Lazio Regional Health Service, Rome, Italy.
Trotta F; Italian Medicines Agency (AIFA), Via del Tritone, 181-00187, Rome, Italy.
Tafuri G; Italian Medicines Agency (AIFA), Via del Tritone, 181-00187, Rome, Italy.
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Źródło :
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2020 Jan; Vol. 54 (1), pp. 195-199. Date of Electronic Publication: 2020 Jan 06.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Drug Approval*
Government Regulation*
Legislation, Drug*
Pharmaceutical Preparations/*standards
Therapies, Investigational/*standards
Australia ; Canada ; Europe ; Humans ; Japan ; United States
Czasopismo naukowe
Tytuł :
To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
Autorzy :
Kühler TC; Global Regulatory Science and Policy, Sanofi SA, Chilly-Mazarin, France .
Bujar M; Centre for Innovation in Regulatory Science, London, UK.
McAuslane N; Centre for Innovation in Regulatory Science, London, UK.
Liberti L; Centre for Innovation in Regulatory Science, London, UK.
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Źródło :
BMJ open [BMJ Open] 2019 Nov 25; Vol. 9 (11), pp. e028677. Date of Electronic Publication: 2019 Nov 25.
Typ publikacji :
Journal Article
MeSH Terms :
Government Regulation*
International Agencies*
Drug Approval/*legislation & jurisprudence
Drug Approval/*organization & administration
International Cooperation/*legislation & jurisprudence
Drug Approval/statistics & numerical data ; Europe ; Humans ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Autorzy :
Salcher-Konrad M; London School of Economics and Political Science.
Naci H; London School of Economics and Political Science.
Davis C; King's College London.
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Źródło :
The Milbank quarterly [Milbank Q] 2020 Dec; Vol. 98 (4), pp. 1219-1256. Date of Electronic Publication: 2020 Oct 06.
Typ publikacji :
Comparative Study; Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Antineoplastic Agents*
Drug Approval/*legislation & jurisprudence
Europe ; Government Regulation ; Humans ; Uncertainty ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
An integrated view on society readiness and initial reaction to COVID-19: A study across European countries.
Autorzy :
Petrović D; Faculty of Transport and Traffic Engineering, University of Belgrade, Belgrade, Serbia.; Faculty of Philosophy, University of Belgrade, Belgrade, Serbia.
Petrović M; Faculty of Philosophy, University of Belgrade, Belgrade, Serbia.
Bojković N; Faculty of Philosophy, University of Belgrade, Belgrade, Serbia.
Čokić VP; Institute for Medical Research, University of Belgrade, Belgrade, Serbia.
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Źródło :
PloS one [PLoS One] 2020 Nov 23; Vol. 15 (11), pp. e0242838. Date of Electronic Publication: 2020 Nov 23 (Print Publication: 2020).
Typ publikacji :
Journal Article
MeSH Terms :
Global Health*
SARS-CoV-2*
COVID-19/*epidemiology
COVID-19/*prevention & control
Pandemics/*prevention & control
Adolescent ; Adult ; Aged ; Aged, 80 and over ; COVID-19/diagnosis ; COVID-19/virology ; Europe/epidemiology ; Female ; Government Regulation ; Humans ; Male ; Mass Screening/methods ; Middle Aged ; Patient Isolation/legislation & jurisprudence ; Patient Isolation/methods ; Physical Distancing ; Quarantine/legislation & jurisprudence ; Quarantine/methods ; Risk Factors ; Young Adult
Czasopismo naukowe
Tytuł :
Regulatory aspects of the development of drugs for metabolic bone diseases - FDA and EMA perspective.
Autorzy :
Kehoe T; United States Food and Drug Administration, Silver Spring, MD, 20993, USA.
Blind E; European Medicines Agency, London, E14 5EU, UK.
Janssen H; European Medicines Agency, London, E14 5EU, UK.
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Źródło :
British journal of clinical pharmacology [Br J Clin Pharmacol] 2019 Jun; Vol. 85 (6), pp. 1208-1212. Date of Electronic Publication: 2018 Dec 03.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Government Regulation*
Bone Density Conservation Agents/*therapeutic use
Bone Diseases, Metabolic/*drug therapy
Bone Remodeling/*drug effects
Drug Approval/*legislation & jurisprudence
Drug Development/*legislation & jurisprudence
United States Food and Drug Administration/*legislation & jurisprudence
Biosimilar Pharmaceuticals/therapeutic use ; Bone Density Conservation Agents/adverse effects ; Bone Diseases, Metabolic/diagnosis ; Bone Diseases, Metabolic/physiopathology ; Drugs, Generic/therapeutic use ; Europe ; Humans ; Patient Safety ; Policy Making ; Product Surveillance, Postmarketing ; Risk Assessment ; Treatment Outcome ; United States
Czasopismo naukowe
Tytuł :
EDCs: regulation still lagging behind evidence.
Autorzy :
The Lancet Diabetes Endocrinology
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Źródło :
The lancet. Diabetes & endocrinology [Lancet Diabetes Endocrinol] 2019 May; Vol. 7 (5), pp. 325. Date of Electronic Publication: 2019 Apr 04.
Typ publikacji :
Editorial
MeSH Terms :
Government Regulation*
Legislation as Topic*
Endocrine Disruptors/*toxicity
Public Health/*legislation & jurisprudence
Environmental Illness/epidemiology ; Environmental Pollutants/toxicity ; Europe ; European Union ; Humans ; Noncommunicable Diseases/epidemiology
Opinia redakcyjna
Tytuł :
Ivabradine for heart failure: regulatory differences in Europe and United States.
Autorzy :
Marciniak TA; Bethany Beach, 39344 Hatteras Drive Bethany Beach, DE, USA.
Hall TS; Department of Cardiology B, Hospital Ullevål and University of Oslo, Boks 1072 Blindern, Oslo, Norway; and.
Atar D; Department of Cardiology B, Hospital Ullevål and University of Oslo, Boks 1072 Blindern, Oslo, Norway; and.
Agewall S; Department of Cardiology B, Hospital Ullevål and University of Oslo, Boks 1072 Blindern, Oslo, Norway; and.
Serebruany VL; Department of Neurology, Stroke Unit, Johns Hopkins University, 600 N. Wolfe Street/Osler 670 Baltimore, MD, USA.
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Źródło :
European heart journal. Cardiovascular pharmacotherapy [Eur Heart J Cardiovasc Pharmacother] 2019 Apr 01; Vol. 5 (2), pp. 119-121.
Typ publikacji :
Letter
MeSH Terms :
Government Regulation*
Cardiovascular Agents/*therapeutic use
Drug Approval/*legislation & jurisprudence
Evidence-Based Medicine/*legislation & jurisprudence
Healthcare Disparities/*legislation & jurisprudence
Heart Failure/*drug therapy
Ivabradine/*therapeutic use
United States Food and Drug Administration/*legislation & jurisprudence
Europe ; Heart Failure/diagnosis ; Heart Failure/physiopathology ; Humans ; Ivabradine/adverse effects ; Patient Safety ; Policy Making ; Risk Assessment ; Risk Factors ; United States
Opinia redakcyjna
Tytuł :
Medical Nutrition Terminology and Regulations in the United States and Europe-A Scoping Review: Report of the ISPOR Nutrition Economics Special Interest Group.
Autorzy :
Freijer K; School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands. Electronic address: .
Volger S; Clinical Development Immunology Gastroenterology, Janssen R&D, Spring House, PA, USA.
Pitter JG; Syreon Research Institute, Budapest, Hungary.
Molsen-David E; Scientific & Health Policy Initiatives, ISPOR, Lawrenceville, NJ, USA.
Cooblall C; Scientific & Health Policy Initiatives, ISPOR, Lawrenceville, NJ, USA.
Evers S; School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands.
Hiligsmann M; Department of Health Services Research of Maastricht University, Maastricht, Netherlands.
Danel A; Nestle Health Science, Vevey, Switzerland.
Lenoir-Wijnkoop I; Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
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Corporate Authors :
ISPOR Nutrition Economics Medical Nutrition Terms & Definitions Working Group’s Leadership Team
Źródło :
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [Value Health] 2019 Jan; Vol. 22 (1), pp. 1-12. Date of Electronic Publication: 2018 Oct 25.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Systematic Review
MeSH Terms :
Government Regulation*
Terminology as Topic*
Dietary Supplements/*classification
Health Policy/*legislation & jurisprudence
Malnutrition/*classification
Malnutrition/*therapy
Nutrition Therapy/*classification
Aged ; Consensus ; Dietary Supplements/economics ; Enteral Nutrition/classification ; Europe/epidemiology ; Female ; Health Care Costs ; Health Policy/economics ; Humans ; Male ; Malnutrition/economics ; Malnutrition/epidemiology ; Middle Aged ; Nutrition Therapy/economics ; Parenteral Nutrition/classification ; Policy Making ; United States/epidemiology
Czasopismo naukowe
Tytuł :
Regulatory watch: European regulatory experience with advanced therapy medicinal products.
Autorzy :
Barkholt L; Medicinal Products Agency, Uppsala, Sweden.
Voltz-Girolt C; European Medicines Agency, London, UK.
Raine J; Medicines and Healthcare Products Regulatory Agency, London, UK.
Salmonson T; Medicinal Products Agency, Uppsala, Sweden.
Schüssler-Lenz M; Paul-Ehrlich-Institut, Langen, Germany.
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Źródło :
Nature reviews. Drug discovery [Nat Rev Drug Discov] 2019 Jan; Vol. 18 (1), pp. 8-9. Date of Electronic Publication: 2018 Nov 30.
Typ publikacji :
Journal Article
MeSH Terms :
Cell- and Tissue-Based Therapy*
Government Regulation*
Biological Products/*therapeutic use
Drug Approval/*legislation & jurisprudence
Drug Discovery/*legislation & jurisprudence
Genetic Therapy/*legislation & jurisprudence
Europe ; Humans
Czasopismo naukowe
Tytuł :
Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine.
Autorzy :
Pregelj L; School of Chemistry and Molecular Biosciences and Australian Institute for Business and Economics, The University of Queensland, St Lucia, Queensland 4072, Australia.
Hine DC; Kemmy Business School, University of Limerick, Limerick, V94 T9PX, Ireland.
Oyola-Lozada MG; School of Chemistry and Molecular Biosciences and Faculty of Business, Economics and Law, The University of Queensland, St Lucia, Queensland 4072, Australia.
Munro TP; Australian Institute for Bioengineering and Nanotechnology, The University of Queensland, St Lucia, Queensland 4072, Australia. Electronic address: .
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Źródło :
Trends in biotechnology [Trends Biotechnol] 2020 Sep; Vol. 38 (9), pp. 943-947. Date of Electronic Publication: 2020 Jun 13.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Coronavirus Infections/*prevention & control
Drug Approval/*organization & administration
Hemorrhagic Fever, Ebola/*prevention & control
Influenza, Human/*prevention & control
Pandemics/*prevention & control
Pneumonia, Viral/*prevention & control
Viral Vaccines/*biosynthesis
Betacoronavirus/drug effects ; Betacoronavirus/immunology ; Betacoronavirus/pathogenicity ; COVID-19 ; COVID-19 Vaccines ; Coronavirus Infections/epidemiology ; Coronavirus Infections/immunology ; Coronavirus Infections/virology ; Ebola Vaccines/administration & dosage ; Ebola Vaccines/biosynthesis ; Ebolavirus/drug effects ; Ebolavirus/immunology ; Ebolavirus/pathogenicity ; Europe/epidemiology ; Global Health/trends ; Government Regulation ; Hemorrhagic Fever, Ebola/epidemiology ; Hemorrhagic Fever, Ebola/immunology ; Hemorrhagic Fever, Ebola/virology ; Humans ; Influenza A Virus, H1N1 Subtype/genetics ; Influenza A Virus, H1N1 Subtype/immunology ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/biosynthesis ; Influenza, Human/epidemiology ; Influenza, Human/immunology ; Influenza, Human/virology ; Middle East Respiratory Syndrome Coronavirus/drug effects ; Middle East Respiratory Syndrome Coronavirus/immunology ; Middle East Respiratory Syndrome Coronavirus/pathogenicity ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/immunology ; Pneumonia, Viral/virology ; SARS Virus/drug effects ; SARS Virus/immunology ; SARS Virus/pathogenicity ; SARS-CoV-2 ; Severe Acute Respiratory Syndrome/epidemiology ; Severe Acute Respiratory Syndrome/immunology ; Severe Acute Respiratory Syndrome/prevention & control ; Severe Acute Respiratory Syndrome/virology ; United States/epidemiology ; Viral Vaccines/administration & dosage ; Zika Virus/drug effects ; Zika Virus/immunology ; Zika Virus/pathogenicity ; Zika Virus Infection/epidemiology ; Zika Virus Infection/immunology ; Zika Virus Infection/prevention & control ; Zika Virus Infection/virology
Czasopismo naukowe
Tytuł :
Assessment of the Regulatory Dialogue Between Pharmaceutical Companies and the European Medicines Agency on the Choice of Noninferiority Margins.
Autorzy :
Althunian TA; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
de Boer A; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; Dutch Medicines Evaluation Board, Utrecht, the Netherlands.
Mantel-Teeuwisse AK; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
Groenwold RHH; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Gispen-de Wied CC; Dutch Medicines Evaluation Board, Utrecht, the Netherlands.
Leufkens HGM; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
Klungel OH; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: .
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Źródło :
Clinical therapeutics [Clin Ther] 2020 Aug; Vol. 42 (8), pp. 1588-1594. Date of Electronic Publication: 2020 Aug 08.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Equivalence Trials as Topic*
Legislation, Drug*
Drug Industry ; Europe ; Government Agencies ; Government Regulation
Czasopismo naukowe
Tytuł :
Clarification of Governance Relevant to the Sustainable Management of Marine Species and Habitats within the United Kingdom: An Overview of Regional, National and International Authorities, Advisories, Legislation and Designation Types with Summary Schematic Tool.
Autorzy :
Mackenzie CL; School of Energy, Geoscience, Infrastructure and Society, Heriot-Watt University, Riccarton, Edinburgh, EH14 4AS, UK. .
Vad J; School of Energy, Geoscience, Infrastructure and Society, Heriot-Watt University, Riccarton, Edinburgh, EH14 4AS, UK.; School of Geoscience, Grant Institute, University of Edinburgh, Edinburgh, EH9 3FE, UK.
MacPherson R; School of Energy, Geoscience, Infrastructure and Society, Heriot-Watt University, Riccarton, Edinburgh, EH14 4AS, UK.
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Źródło :
Environmental management [Environ Manage] 2018 Oct; Vol. 62 (4), pp. 631-643. Date of Electronic Publication: 2018 Jun 17.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Review
MeSH Terms :
Ecosystem*
Endangered Species*
Government Regulation*
Aquatic Organisms/*growth & development
Conservation of Natural Resources/*legislation & jurisprudence
Conservation of Natural Resources/*methods
Animals ; Environmental Policy/legislation & jurisprudence ; Europe ; Internationality ; United Kingdom
Czasopismo naukowe
Tytuł :
Attitudes towards tobacco product regulations and their relationship with the tobacco control policies.
Autorzy :
Lidón-Moyano C; Group of Evaluation of Health Determinants and Health Policies, Department of Basic Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
Sampedro-Vida M; Group of Evaluation of Health Determinants and Health Policies, Department of Basic Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
Matilla-Santander N; Group of Evaluation of Health Determinants and Health Policies, Department of Basic Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
Martín-Sánchez JC; Group of Evaluation of Health Determinants and Health Policies, Department of Basic Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
González-Marrón A; Group of Evaluation of Health Determinants and Health Policies, Department of Basic Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
Bunch K; Group of Evaluation of Health Determinants and Health Policies, Department of Basic Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.
Martínez-Sánchez JM; Group of Evaluation of Health Determinants and Health Policies, Department of Basic Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain; Tobacco Control Unit, Cancer Prevention and Control Program, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain; Cancer Prevention and Control Group, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: .
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Źródło :
Preventive medicine [Prev Med] 2018 Jun; Vol. 111, pp. 67-72. Date of Electronic Publication: 2018 Feb 21.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Attitude*
Government Regulation*
Tobacco Products*
Product Labeling/*legislation & jurisprudence
Public Policy/*trends
Cross-Sectional Studies ; Europe/epidemiology ; Humans ; Prevalence ; Smoke-Free Policy/legislation & jurisprudence ; Smoking/epidemiology ; Taxes/economics
Czasopismo naukowe

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