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The FDA and Genomic Tests — Getting Regulation Right

Year: 2015

Type: article

Abstract: The authors review the nature of the proposal by the FDA for the regulation of next-generation sequencing and laboratory-developed tests in clinical medicine and offer thoughts on what is needed to protect consumers and foster innovation.

Source: New England Journal of Medicine

DOI: 10.1056/nejmsr1501194

Authors: Barbara J. Evans, Wylie Burke, Gail P. Jarvik

Institutions: University of Washington, University of Houston

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: bronze

Funder: National Human Genome Research Institute

Awards: CSER RoRC Centralized Support Coordinating Center, G4748628049

OpenAlex ID: W2327499427

FWCI: 14.71

Cites: 13

Cited by: 79

Related to: 10