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FDA User Fees In FY 2014: Burden Per Application Grows As Submission Projections Fall

 
• By Derrick Gingery

Agency announces new prescription drug, generic drug and biosimilar rates – with one fee increasing more than 47%.

FDA’s fiscal year 2014 user fee rates for the prescription drug, generic drug and biosimilar programs include some expected and unexpected increases, and also underscore the still-embryonic status of BsUFA.

Industry will once again pay more for application reviews, facility inspections and other agency services during the upcoming fiscal year. Fees across the three programs increased at least 5%, with...

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More from North America

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