Louisiana Research Center Receives FDA Warning Letter over IRB Operational Concerns

J.W. Schomisch
October 15, 2024 at 12:29 PM EST
The FDA sent a Warning Letter to Louisiana State University Health Science Center over concerns about the operation of the center’s institutional review board (IRB). The Sept. 27 Warning Letter alleged the IRB failed to conduct continuing review of research at least once a year (21 C.F.R. §56.109(f)) and failed to prepare, maintain and follow required written procedures for e... Read More

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