Vaccines, Blood & Biologics

Impact of FDA Lapse in Funding on CBER Activities

During the government shutdown, CBER will continue vital activities that are critical to ensuring public health and safety in the United States, consistent with the law and to support activities funded by carryover user fee (BSUFA, PDUFA, MDUFA & GDUFA) balances.
 
This statement clarifies CBER’s position regarding review of Investigational New Drug Applications (INDs) during this shutdown.  For INDs covered by PDUFA carryover, CBER will continue review of existing INDs and accept new INDs, amendments, annual reports, etc. For INDs not covered by PDUFA user fees, FDA will suspend review of existing INDs and associated submissions, and will not review any newly submitted INDs, except for emergency INDs and new IND amendments that relate to the safety of human subjects.
 

Page Last Updated: 12/26/2018
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