The FDA's Experience with Covid-19 Antibody Tests

N Engl J Med. 2021 Feb 18;384(7):592-594. doi: 10.1056/NEJMp2033687. Epub 2021 Feb 13.

Authors

Jeffrey Shuren¹, Timothy Stenzel¹

Affiliation

¹ From the Food and Drug Administration, Silver Spring, MD.

PMID: 33605568
DOI: 10.1056/NEJMp2033687

No abstract available

MeSH terms

COVID-19 Serological Testing / standards*
Clinical Laboratory Techniques / standards
Diagnostic Test Approval* / legislation & jurisprudence
Federal Government
Government Regulation*
Humans
Laboratories / legislation & jurisprudence
Laboratories / standards
Marketing of Health Services / legislation & jurisprudence*
Organizational Policy
United States
United States Food and Drug Administration* / organization & administration