Shutdown Puts FDA Drug and Device Facility Registration on Hold
The Food and Drug Administration won’t be accepting facility registrations for drug and device production and distribution facilities during the federal government shutdown, despite the beginning of the registration period Oct. 1. All drug and device facilities that market their…
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products in the U.S. are required by law to register, including foreign facilities whose drugs and devices are imported into the U.S. But without a fiscal year 2014 budget, FDA said it has no legal authority to collect user fees associated with the registrations. The drug and device facility registration period runs until Dec. 31. The registration user fee for FY 2014 is $3,313.