FloodLAMP FDA COVID-19 Diagnostic Test EUA Staffing and Review Timing
Compilation of publicly available data on FDA staffing levels and review timelines for COVID-19 diagnostic test (molecular and antigen) EUAs, covering CDRH OHT7/OIR workforce growth from 60 to 180 staff, review-time trends from 14-day to 99-day medians and back, submission outcomes and refusal reasons, and the key federal sources for each metric.
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_AI_FDA COVID-19 Diagnostic Test EUA Staffing and Review Timing.md
regulatory/fda-policy/_AI_FDA COVID-19 Diagnostic Test EUA Staffing and Review Timing.md
2026_03_22
Created by ChatGPT 5.4 Pro during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Synthesizes two separate ChatGPT responses on FDA staffing and review timing for COVID-19 diagnostic test EUAs, drawing on GAO-22-104266, FDA's Deliverable 15 EUA Assessment, MDUFA V meeting records, HHS OIG evaluation OEI-01-20-00380, and FDA annual MCMi reports and congressional testimony. Filtered to exclude non-diagnostic EUAs (serology, therapeutics, vaccines, non-IVD devices).
COVID-19, diagnostics, EUA, FDA, staffing, review-timing, CDRH, OHT7, OIR
md
CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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