Addressing The Device Backlog: Government Shutdown Ends, Now FDA Has To Catch Up
This article was originally published in The Pink Sheet Daily
Executive Summary
After the shutdown, FDA staff are facing a backlog of fiscal year 2014 device submissions. The agency is working on a plan and assessing its ability to meet its MDUFA III commitments. The bigger concern, however, may be the regulatory uncertainty created by the short-term deal in Congress.
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