With Republicans and Democrats still at a stand-off, federal funded services are being affected - from National Park closures to penguin studies in Antarctica - causing the US Food and Drug Administration (FDA) to release an updated list of activities it anticipates will be affected by the shutdown.
FDA spokesperson Stephen King told in-Pharmatechnologist.com the FDA’s statement issued at the start of this ‘lapse period’ still stood, limiting the FDA’s activities to: emergency work involving the safety of human life, criminal law enforcement work, and activities funded by carryover user fee balances.
The updated list published on Monday this week adds further information, including the FDA being unable to accept any regulatory submissions that require a fee payment and that are submitted during the lapse period.
The agency does not anticipate the shutdown will affect routine product review process for submissions within the scope of the Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA) programmes, though fees had to have been paid before October 1.
The full list of the FDA’s scope during this period can be found here.