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How much does it cost to get a drug FDA approved?

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ever wonder what it costs to get a drug into the fda ?

wonder no more!

FY 2018 user fee rates (posted 9/15/2017):
Application Fee – Clinical Data Required    $2,421,495
Application Fee – No Clinical Data Required    $1,210,748
Program Fee    $304,162

in case you were still wondering, yes, the prices have been going up. going up a lot.

FY 2017 user fee rates (posted 7/28/2016):Application w/Clinical     $2,038,100
Application w/o Clinical     $1,019,050
Supplement w/Clinical     $1,019,050
Product     $97,750
Establishment     $512,200


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