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FDAnews Drug Daily Bulletin
Nov. 7, 2012 | Vol. 9 No. 219
Indiana Hospital IRB Warned for Inadequate Pediatric Protections
The FDA has handed a warning letter to the Memorial Hospital of South Bend institutional review board (IRB) for failing to adequately protect child participants in clinical trials. During an April inspection, the FDA found multiple violations, including failure to make sure three trials enrolling children comply with subsections of 21 CFR Part 50. Those regulations provide additional safeguards for children in clinical investigations.
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