The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation

The regulatory landscape for precision oncology in the United States is complicated, with multiple governmental regulatory agencies with different scopes of jurisdiction. Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate la...

Descripción completa

Detalles Bibliográficos
Autor principal: Konnick, Eric Q.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7261109/
https://www.ncbi.nlm.nih.gov/pubmed/32509953
http://dx.doi.org/10.1016/j.plabm.2020.e00172
_version_ 1783540446971035648
author Konnick, Eric Q.
author_facet Konnick, Eric Q.
author_sort Konnick, Eric Q.
collection PubMed
description The regulatory landscape for precision oncology in the United States is complicated, with multiple governmental regulatory agencies with different scopes of jurisdiction. Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate laboratory-developed tests in 2014. Key aspects of the most recent proposals and discussion of central arguments related to the regulation of precision oncology laboratory tests provides insight to stakeholders for future discussions related to regulation of laboratory tests.
format Online
Article
Text
id pubmed-7261109
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Elsevier
record_format MEDLINE/PubMed
spelling pubmed-72611092020-06-01 The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation Konnick, Eric Q. Pract Lab Med Article The regulatory landscape for precision oncology in the United States is complicated, with multiple governmental regulatory agencies with different scopes of jurisdiction. Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate laboratory-developed tests in 2014. Key aspects of the most recent proposals and discussion of central arguments related to the regulation of precision oncology laboratory tests provides insight to stakeholders for future discussions related to regulation of laboratory tests. Elsevier 2020-05-30 /pmc/articles/PMC7261109/ /pubmed/32509953 http://dx.doi.org/10.1016/j.plabm.2020.e00172 Text en © 2020 The Author http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Konnick, Eric Q.
The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation
title The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation
title_full The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation
title_fullStr The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation
title_full_unstemmed The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation
title_short The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation
title_sort regulatory landscape of precision oncology laboratory medicine in the united states – perspective on the past 5 years and considerations for future regulation
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7261109/
https://www.ncbi.nlm.nih.gov/pubmed/32509953
http://dx.doi.org/10.1016/j.plabm.2020.e00172
work_keys_str_mv AT konnickericq theregulatorylandscapeofprecisiononcologylaboratorymedicineintheunitedstatesperspectiveonthepast5yearsandconsiderationsforfutureregulation
AT konnickericq regulatorylandscapeofprecisiononcologylaboratorymedicineintheunitedstatesperspectiveonthepast5yearsandconsiderationsforfutureregulation

Ejemplares similares