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Wyszukujesz frazę ""Product Surveillance, Postmarketing"" wg kryterium: Temat


Tytuł:
Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency.
Autorzy:
Herder M; Faculties of Medicine and Law, Dalhousie University.
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Źródło:
The Milbank quarterly [Milbank Q] 2019 Sep; Vol. 97 (3), pp. 820-857. Date of Electronic Publication: 2019 Aug 12.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Government Regulation*
Product Surveillance, Postmarketing*
United States Food and Drug Administration*
Interviews as Topic ; Program Evaluation ; Qualitative Research ; United States
Czasopismo naukowe
Tytuł:
Quantitative Bias Analysis in Regulatory Settings.
Autorzy:
Lash TL; Timothy L. Lash is with the Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA. Matthew P. Fox is with the Department of Epidemiology, Boston University School of Public Health, Boston, MA. At the time of the study, Darryl Cooney was with SciMetrika LLC, Durham, NC. Yun Lu and Richard A. Forshee are with the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Fox MP; Timothy L. Lash is with the Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA. Matthew P. Fox is with the Department of Epidemiology, Boston University School of Public Health, Boston, MA. At the time of the study, Darryl Cooney was with SciMetrika LLC, Durham, NC. Yun Lu and Richard A. Forshee are with the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Cooney D; Timothy L. Lash is with the Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA. Matthew P. Fox is with the Department of Epidemiology, Boston University School of Public Health, Boston, MA. At the time of the study, Darryl Cooney was with SciMetrika LLC, Durham, NC. Yun Lu and Richard A. Forshee are with the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Lu Y; Timothy L. Lash is with the Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA. Matthew P. Fox is with the Department of Epidemiology, Boston University School of Public Health, Boston, MA. At the time of the study, Darryl Cooney was with SciMetrika LLC, Durham, NC. Yun Lu and Richard A. Forshee are with the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
Forshee RA; Timothy L. Lash is with the Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA. Matthew P. Fox is with the Department of Epidemiology, Boston University School of Public Health, Boston, MA. At the time of the study, Darryl Cooney was with SciMetrika LLC, Durham, NC. Yun Lu and Richard A. Forshee are with the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
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Źródło:
American journal of public health [Am J Public Health] 2016 Jul; Vol. 106 (7), pp. 1227-30. Date of Electronic Publication: 2016 May 19.
Typ publikacji:
Journal Article
MeSH Terms:
Bias*
Research Design*
Product Surveillance, Postmarketing/*methods
United States Food and Drug Administration/*organization & administration
Humans ; Uncertainty ; United States
Czasopismo naukowe
Tytuł:
New law gives FDA more influence to monitor drug safety.
Autorzy:
Wadman M
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Źródło:
Nature medicine [Nat Med] 2007 Nov; Vol. 13 (11), pp. 1269.
Typ publikacji:
Wiadomości
MeSH Terms:
Drug-Related Side Effects and Adverse Reactions*
Product Surveillance, Postmarketing*
United States Food and Drug Administration/*legislation & jurisprudence
Clinical Trials as Topic ; United States
Periodyk
Tytuł:
Tempered enthusiasm. Drug-safety law needs more teeth, patient-safety advocates say.
Autorzy:
DerGurahian J
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Źródło:
Modern healthcare [Mod Healthc] 2007 Oct 08; Vol. 37 (40), pp. 16.
Typ publikacji:
Wiadomości
MeSH Terms:
Product Surveillance, Postmarketing*/economics
Drug Approval/*legislation & jurisprudence
United States Food and Drug Administration/*legislation & jurisprudence
Drug Approval/economics ; Drug Industry/economics ; Drug Industry/legislation & jurisprudence ; Liability, Legal/economics ; Patient Advocacy ; United States
Periodyk
Tytuł:
Delayed scrutiny: Reported problems with birth control device expose gaps in FDA post-market surveillance.
Autorzy:
Rice S
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Źródło:
Modern healthcare [Mod Healthc] 2015 Jul 27; Vol. 45 (30), pp. 16-8.
Typ publikacji:
Journal Article
MeSH Terms:
Medical Device Recalls*
United States Food and Drug Administration*
Contraception/*instrumentation
Product Surveillance, Postmarketing/*standards
United States
Czasopismo naukowe
Tytuł:
Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.
Autorzy:
Abe AM; Andrew M. Abe, Pharm.D., is Assistant Professor, Pharmacy Practice, and Drug Information Specialist, School of Pharmacy, The University of Kansas, Lawrence. Darren J. Hein, Pharm.D., is Assistant Professor, Pharmacy Practice; and Philip J. Gregory, Pharm.D., M.S., FACN, is Associate Professor, Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, NE. .
Hein DJ; Andrew M. Abe, Pharm.D., is Assistant Professor, Pharmacy Practice, and Drug Information Specialist, School of Pharmacy, The University of Kansas, Lawrence. Darren J. Hein, Pharm.D., is Assistant Professor, Pharmacy Practice; and Philip J. Gregory, Pharm.D., M.S., FACN, is Associate Professor, Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, NE.
Gregory PJ; Andrew M. Abe, Pharm.D., is Assistant Professor, Pharmacy Practice, and Drug Information Specialist, School of Pharmacy, The University of Kansas, Lawrence. Darren J. Hein, Pharm.D., is Assistant Professor, Pharmacy Practice; and Philip J. Gregory, Pharm.D., M.S., FACN, is Associate Professor, Pharmacy Practice, Center for Drug Information and Evidence-Based Practice, School of Pharmacy and Health Professions, Creighton University, Omaha, NE.
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Źródło:
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2015 Jun 01; Vol. 72 (11), pp. 966-71.
Typ publikacji:
Journal Article
MeSH Terms:
Consumer Product Safety/*legislation & jurisprudence
Dietary Supplements/*statistics & numerical data
Product Surveillance, Postmarketing/*statistics & numerical data
United States Food and Drug Administration/*legislation & jurisprudence
Canada ; Drug Contamination/statistics & numerical data ; Drug Packaging ; Humans ; United States
Czasopismo naukowe
Tytuł:
Opening Pandora's pillbox: using modern information tools to improve drug safety.
Autorzy:
Gottlieb S; American Enterprise Institute in Washington, DC, USA.
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Źródło:
Health affairs (Project Hope) [Health Aff (Millwood)] 2005 Jul-Aug; Vol. 24 (4), pp. 938-48.
Typ publikacji:
Journal Article
MeSH Terms:
Adverse Drug Reaction Reporting Systems*
Drug Approval/*methods
Product Surveillance, Postmarketing/*methods
United States Food and Drug Administration/*organization & administration
Aged ; Centers for Medicare and Medicaid Services, U.S. ; Data Collection/methods ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Internet ; Medicare ; Product Surveillance, Postmarketing/standards ; Research Design ; Safety ; United States
Czasopismo naukowe
Tytuł:
Regulatory reticence and medical devices.
Autorzy:
Fox DM; Milbank Memorial Fund.
Zuckerman DM
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Źródło:
The Milbank quarterly [Milbank Q] 2014 Mar; Vol. 92 (1), pp. 151-9.
Typ publikacji:
Journal Article; Comment
MeSH Terms:
Device Approval/*legislation & jurisprudence
Device Approval/*standards
Equipment Safety/*standards
Equipment and Supplies/*standards
Product Surveillance, Postmarketing/*standards
United States Food and Drug Administration/*legislation & jurisprudence
Humans
Czasopismo naukowe

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