Phillips and Dinakar - A Proposal for Increasing the Speed of Validating SARS-CoV-2 Diagnostic Tests Phillips and Dinakar's proposal paper (v0.1.9, January 2021) recommends three extensions to the FDA's EUA process for accelerating validation of SARS-CoV-2 diagnostic tests: structured (machine-readable) EUA data submissions, distributed FDA-directed CLIA-led validation leveraging existing laboratory expertise, and building an open synthetic patient clinical specimen panel to reduce dependence on limited clinical samples for test validation. primary file regulatory reg-articles-misc 2021-01-18_Phillips and Dinakar - A Proposal for Increasing the Speed of Validating SARS-CoV-2 Diagnostic Tests.md regulatory/reg-articles-misc/2021-01-18_Phillips and Dinakar - A Proposal for Increasing the Speed of Validating SARS-CoV-2 Diagnostic Tests.md 2021_01_18 pdf 3rd Party 4928 8418 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url