FDA User Fees In FY 2014: Burden Per Application Grows As Submission Projections Fall
Agency announces new prescription drug, generic drug and biosimilar rates – with one fee increasing more than 47%.
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NDA/BLAs with clinical data will cost 7.7% more starting Oct. 1, bringing the application fee to $2.34 million.
FDA increases “complete response” and refuse-to-receive actions in the first half of FY 2014 compared to the previous year, efforts the agency says will move pending applications closer to approval.
Industry avoided application supplement fees by using CBE submissions instead, forcing FDA to change its estimates and sending generic drug user fees higher.