New England IRB Announces Results of FDA Audit
WELLESLEY, Mass.-(Business Wire)-September 21, 2009 - New England IRB is pleased to announce that FDA has sent written notification that the results of their audit conducted in November 2008 indicate no significant findings. No further action is required.
In the current climate of increased scrutiny on Institutional Review Boards (IRBs), this is welcome news. "Having six plus years of AAHRPP accreditation under our belts, this is not unexpected news," says NEIRB Vice President James Saunders. "However, given the scrutiny that IRBs are under these days, we need to be constantly vigilant that we maintain our high standards. We have set up our Standard Operating Procedures (SOPs) to ensure that we are always at the top of our game."
In addition to receiving official notification of clean audit results, New England IRB has also completed the registration process required by FDA and OHRP final rules mandating new or expanded registration of institutional review boards. Registration numbers for all three review boards can be found on the Regulatory Status page of our website.
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