Literature DB >> 31570544

Health Canada needs to act on laboratory-developed diagnostics.

Kelly Holloway1, Fiona A Miller2, François Rousseau1, Alberto Gutierrez1, Stuart Hogarth1.   

Abstract

Mesh：

Year:  2019        PMID： 31570544      PMCID： PMC6773549          DOI： 10.1503/cmaj.190550

Source DB:  PubMed          Journal:  CMAJ        ISSN： 0820-3946            Impact factor:   8.262


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  4 in total

Review 1.  Laboratory quality regulations and accreditation standards in Canada.

Authors:  Hui Li; Khosrow Adeli
Journal:  Clin Biochem       Date:  2009-03       Impact factor: 3.281

2.  Dangerous diagnostics? Regulatory reform in the genomic era.

Authors:  Kelly Holloway; Fiona A Miller; Alberto Gutierrez; Stuart Hogarth
Journal:  BMJ       Date:  2019-02-19

3.  Accountability through regulation in Ontario's Medical Laboratory Sector.

Authors:  Brenda Gamble; Lavern Bourne; Raisa B Deber
Journal:  Healthc Policy       Date:  2014-09

4.  The role of laboratory medicine in healthcare: quality requirements of immunoassays, standardisation and data management in prospective medicine.

Authors:  Thomas Waerner; Dietmar Thurnher; Kurt Krapfenbauer
Journal:  EPMA J       Date:  2010-12-02       Impact factor: 6.543
  4 in total
  4 in total

1.  The Canadian Standards Association Technical Committee Z252.11 for Lab-developed Tests provides information.

Authors:  Edward Dunn; Robert Rennie
Journal:  CMAJ       Date:  2020-10-05       Impact factor: 8.262

2.  Regulatory oversight for research tests and laboratory-developed diagnostics should be more nimble.

Authors:  Donna M Berry; Rulan S Parekh; Meredith S Irwin
Journal:  CMAJ       Date:  2019-12-16       Impact factor: 8.262

3.  Regulation of Molecular Farming Products.

Authors:  Penny A C Hundleby; Marc-André D'Aoust; Carolyn Finkle; Judith Atkins; Richard M Twyman
Journal:  Methods Mol Biol       Date:  2022

Review 4.  Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).

Authors:  Folker Spitzenberger; Jaimin Patel; Inga Gebuhr; Klaus Kruttwig; Abdulrahim Safi; Christian Meisel
Journal:  Ther Innov Regul Sci       Date:  2021-07-21       Impact factor: 1.778
  4 in total

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