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 Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate la...
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2020-08-01
|
| Series: | Practical Laboratory Medicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352551719301040 |
| _version_ | 1818479511292870656 |
|---|---|
| author | Eric Q. Konnick |
| author_facet | Eric Q. Konnick |
| author_sort | Eric Q. Konnick |
| collection | DOAJ |
| 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 Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate laboratory-developed tests in 2014.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. |
| first_indexed | 2024-12-10T11:11:38Z |
| format | Article |
| id | doaj.art-b4e9795d8b964938995c8ccbfc8ee695 |
| institution | Directory Open Access Journal |
| issn | 2352-5517 |
| language | English |
| last_indexed | 2024-12-10T11:11:38Z |
| publishDate | 2020-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Practical Laboratory Medicine |
| spelling | doaj.art-b4e9795d8b964938995c8ccbfc8ee6952022-12-22T01:51:24ZengElsevierPractical Laboratory Medicine2352-55172020-08-0121e00172The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulationEric Q. Konnick0Department of Laboratory Medicine, University of Washington, Seattle, WA, USAThe 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.http://www.sciencedirect.com/science/article/pii/S2352551719301040OncologyRegulationTestingLDTsFDACLIA |
| spellingShingle | Eric Q. Konnick The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation Practical Laboratory Medicine Oncology Regulation Testing LDTs FDA CLIA |
| 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 | Oncology Regulation Testing LDTs FDA CLIA |
| url | http://www.sciencedirect.com/science/article/pii/S2352551719301040 |
| work_keys_str_mv | AT ericqkonnick theregulatorylandscapeofprecisiononcologylaboratorymedicineintheunitedstatesperspectiveonthepast5yearsandconsiderationsforfutureregulation AT ericqkonnick regulatorylandscapeofprecisiononcologylaboratorymedicineintheunitedstatesperspectiveonthepast5yearsandconsiderationsforfutureregulation |