Home » FDA Imposes IRB Sanction, Citing Review, Documentation Failures
FDA Imposes IRB Sanction, Citing Review, Documentation Failures
The FDA has stopped enrollment in ongoing device studies reviewed by the Genetics & IVF Institute institutional review board (IRB) because
of continuing review, expedited review and record-keeping failures. The agency will lift the sanction once the Fairfax, Va., IRB demonstrates it has taken
adequate corrective actions, according to a Dec. 23 warning letter posted
last month. The IRB has submitted a corrective action plan, but the FDA must confirm it, Genetics & IVF Institute
spokeswoman Trina Leonard said. Because the implementation of the proposed plan is ongoing, the IRB is still not reviewing or approving new studies, she
added.
Clinical Trials Advisor
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