The “Program’s” Outside Contractor: Eastern Research Group
This article was originally published in RPM Report
FDA has hired an outside firm, Eastern Research Group, to help assess the performance of the new review “Program” for novel drugs and biologics under PDUFA V. That assessment – which will be discussed at two public meetings – will help determine the future of FDA’s new review process after 2017.
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The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.
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