GDUFA Grace Period For Facility Fees Appears To Be Over
This article was originally published in The Pink Sheet Daily
FDA’s drastically expanded arrears list for FY 2014 fees totals more than 100 generic drug facilities; more than 40 still owe the FY 2013 fee.
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Small business owners say the GDUFA facility and other fees are too expensive, especially while waiting for ANDAs to be approved, but any small business waiver is unlikely until GDUFA II.
Bangladesh-based Square Pharmaceuticals says the fees are burdensome for first-time filers, given long approval times, but the firm’s citizen petition strategy may further delay approval of its ANDA.
Industry officials say sponsors have to police all the facilities they use and reference to make sure ANDAs are not held up or exclusivity lost.