MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds
In newly published meeting minutes, industry and the US FDA continued to clash over a proposal to create a new pre-submission advisory program and what to do with carryover user-fee funds.
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The agency published minutes from three MDUFA V user fee meetings with medtech industry. The talks include conversations about carryover funds and filling FTEs from past user fee deals.
Agency would get $300m, half going to modernizing its IT systems. It recently ran into disagreement with industry after using user fees to pay for some upgrades.
The US regulatory agency would get $300m, of which half would be to modernize its IT systems. Recently, it’s run into some disagreement with industry after using user fees to pay for some upgrades.