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

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

THURSDAY, Jan. 17, 2019 (HealthDay News) — Due to the federal government shutdown, the U.S. Food and Drug Administration has only about five weeks of funding left to review new drug applications, according to Commissioner Scott Gottlieb, M.D.

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 three months of funding for medical devices.

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

CNN News Article

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