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BioWorld - Saturday, April 1, 2023
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Home » FDA financial report discloses carry-over balances, disallowance of third-party inspections
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FDA financial report discloses carry-over balances, disallowance of third-party inspections

March 8, 2023
By Mark McCarty
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The FDA’s device center just released three performance reports related to the fourth and fifth device user fee agreements, including a financial report that shows the agency collected far more in user fees than it spent for fiscal year 2022, yielding a carryover amount of more than $142 million. One of the more interesting aspects of the report is that because the taxpayer dollars used for FDA’s device inspections did not meet a pre-specified amount for two consecutive years, third-party inspections for FDA compliance purposes have been disallowed for fiscal year 2023, making hash of a program sought by domestic manufacturers who distribute their products to other nations as well as in the U.S.
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