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How US FDA's Assumptions Impacted Generic Program Fees

 
• By Derrick Gingery

FDA decided against trying to predict upcoming approvals as part of FY 2019 GDUFA program fee calculations, but other adjustments likely increased fee significantly.

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The US FDA decided not to adjust the FY 2019 GDUFA program fee to account for firms that could jump tiers in the middle of the fiscal year, potentially saving ANDA owners some money.

FDA also changed a variable that was used in its calculations, another example of FDA learning how to use its data to ensure the user fee revenue generated is adequate.

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