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Prescription drug and biosimilar user fees to see major discounts in 2017

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FDA has lowered some of the fees for new drug applications (NDAs) and biologic license applications (BLAs) by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016.

FDA has lowered some of the fees for new drug applications (NDAs) and biologic license applications (BLAs) by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016. For an NDA not requiring clinical data or a supplement requiring clinical data, or a biosimilar biological product supplement with clinical data, the user fee is $1,019,050, which is $168,050 less than the fee for 2016. Establishment fees for 2017 will amount to $512,200, which is $73,000 less than 2016, and the 2017 fee for a new prescription drug or biosimilar product is $97,750, which is $16,700 less than 2016’s fee rate and more than $6,000 less than the fee for 2014. FDA also estimates that it will either waive or reduce fees for 16 establishments and that another 16 establishment fees will be exempted this year because of an orphan drug exemption, meaning FDA is expecting a net of 491 fee-paying establishments.

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http://www.raps.org/Regulatory-Focus/News/2016/07/27/25403/Prescription-Drug-and-Biosimilar-User-Fees-to-See-Major-Discounts-in-2017/

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