FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science

JAMA. 2015 Feb 17;313(7):667-8. doi: 10.1001/jama.2014.18135.

Author

Joshua Sharfstein¹

Affiliation

¹ Department of Health and Mental Hygiene, Baltimore, Maryland.

PMID: 25560381
DOI: 10.1001/jama.2014.18135

No abstract available

MeSH terms

Clinical Laboratory Techniques / standards*
Government Regulation*
Humans
United States
United States Food and Drug Administration*