FloodLAMP FDA SARS-CoV-2 Reference Panel Report: Discrepancies, Governance, and EUA Policy Implications
FloodLAMP FDA SARS-CoV-2 Reference Panel Report: Discrepancies, Governance, and EUA Policy Implications synthesizes the complaint record, FDA's 2023 response, the comparative LoD data, and relevant scientific literature to assess what the reference panel did well, what remained unresolved, and what this episode implies for diagnostic EUA policy. It argues that the core concept of a common benchmark was sound, but that FDA's transparency, discrepancy-resolution process, and follow-through were inadequate.
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_AI_FDA SARS-CoV-2 Reference Panel Report - Discrepancies, Governance, and EUA Policy Implications.md
regulatory/fda-policy/_AI_FDA SARS-CoV-2 Reference Panel Report.md
2026_03_20
Created by GPT-5.4 Pro during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Analyzes the FDA SARS-CoV-2 Reference Panel using the uploaded complaint letter, FDA response letter, McFarlane comparative-data compilation, the Blommel peer-reviewed paper, and additional official FDA, GAO, HHS OIG, WHO/NIBSC, and scientific literature on reference materials, benchmarking, harmonization, and EUA policy.
SARS-CoV-2, COVID-19, diagnostics, EUA, FDA, reference-panel, diagnostic-policy
md
CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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