FDA Response Letter - To Compliant regarding FDA Reference Panel from Dec 2020 The FDA letter dated September 29, 2023 responds to an Information Quality Act request from a law firm seeking removal of the FDA SARS-CoV-2 Reference Panel Comparative Data, claiming it was inaccurate and harmed EUA test developers. FDA explains the reference panel and protocol were scientifically sound for comparing relative limits of detection across assays, that participation and public posting were conditions of EUA authorization, and that variability in posted results supports the panel’s validity rather than a systemic flaw. It notes FDA later stopped distributing the reference panel when materials reached effective expiration and removed the comparative data from its website as outdated, denying requests for a public statement blaming accuracy concerns or for additional validation data publication. primary file regulatory fda-policy 2023-09-23_FDA Response Letter - To Compliant regarding FDA Reference Panel from Dec 2020.md regulatory/fda-policy/2023-09-23_FDA Response Letter - To Compliant regarding FDA Reference Panel from Dec 2020.md 2023_09_23 Unsure about license pdf Public Domain 3051 4124 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