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A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnos...

A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnos...

https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_jstor_primary_27098106

A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics

About this item

Full title

A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics

Publisher

Food and Drug Law Institute (FDLI)

Journal title

Food and drug law journal, 2021-01, Vol.76 (3), p.398-440

Language

English

Formats

Publication information

Publisher

Food and Drug Law Institute (FDLI)

More information

Scope and Contents

Contents

Addressing the COVID-19 pandemic has created many challenges for the Food and Drug Administration (FDA). One of the largest challenges in coping with COVID-19 has stemmed from the ongoing need for access to accurate diagnostic tests for the virus. FDA has well-established programs for reviewing in vitro diagnostic (IVD) tests. The agency also has h...

Alternative Titles

Full title

A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics

Authors, Artists and Contributors

Identifiers

Primary Identifiers

Record Identifier

TN_cdi_jstor_primary_27098106

Permalink

https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_jstor_primary_27098106

Other Identifiers

ISSN

1064-590X

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