About Three Months' Worth Of Carryover Device Fees Remaining, FDA's Gottlieb Says
US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.
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FDA Will Have To Scrape By On Continuing Resolution Funding Through December, Legislative Experts Predict
While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.
As the partial US government shutdown enters its second month, the backlog of device pre-market applications is building. AdvaMed is proposing language that would allow FDA to accept and review new user-fee-funded submissions during government shutdowns.
Bolus of applications could be filed once government reopens, but employee morale and recruitment efforts could suffer drop-off.