User Fee Program Six-Month Metrics
After six months under the new prescription drug, generic drug and biosimilar user fee programs, FDA has shown some progress in collecting the necessary fees and conducting sponsor meetings required under the new programs.
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Four warning letters this year have gone to companies that owe finished dosage form and active pharmaceutical ingredient facility fees.
Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.
Twenty sponsors now have applications in the new review model, but none have reached the approval decision stage; industry officials say it still is too early to draw conclusions.