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28 May 2025
// RAPS
https://www.raps.org/news-and-articles/news-articles/2025/5/fda-hands-drugmaker,-diagnostics-firm-warning-lett

01 Feb 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216786

25 Oct 2022
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216216
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