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

Eric Q. Konnick | Zendy

Open Access

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

Author(s) -

Eric Q. Konnick

Publication year - 2020

Publication title -

practical laboratory medicine

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.399

H-Index - 11

ISSN - 2352-5517

DOI - 10.1016/j.plabm.2020.e00172

Subject(s) - jurisdiction , food and drug administration , regulatory science , perspective (graphical) , regulatory affairs , political science , engineering ethics , medicine , public administration , engineering , pharmacology , computer science , law , pathology , artificial intelligence

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 Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate laboratory-developed tests in 2014.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.

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