FDA Down to 5 Weeks of Funding to Review New Drug Applications

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Agency cannot accept new fees or applications until the shutdown is over
Agency cannot accept new fees or applications until the shutdown is over

(HealthDay News) -- Due to the federal government shutdown, the US Food and Drug Administration has only about 5 weeks of funding left to review new drug applications, according to Commissioner Scott Gottlieb, MD.

To keep reviewing applications, the FDA has stretched those funds, which come from user fees paid by drug companies before the shutdown, Gottlieb said Monday on Twitter.

The FDA cannot accept new fees or applications until the shutdown is over, CNN reported. However, blood- and allergy-related products are not covered by the user fee program "so routine review activity ceased related to new products in these categories," Gottlieb said. He also said the FDA has about 3 months of funding for medical devices.

The partial shutdown began on Dec. 22 and on Jan. 12 became the longest government shutdown in US history.

Reference

Nedelman M. The FDA has five weeks till money runs out for approving new drugs. CNN; January 16, 2019. Article

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