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 Diagnostics
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Food and Drug Law Institute (FDLI)
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English
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Food and Drug Law Institute (FDLI)
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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...
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A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics
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TN_cdi_jstor_primary_27098106
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https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_jstor_primary_27098106
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1064-590X