GDUFA Facility Self-Identification Is Key Element For Speedy ANDA Approval
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.
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Fewer generic drug facilities have self-identified with the agency than the same time in 2013, perhaps due to their capital situation.
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.
Fewer API and finished dosage form facilities appear on the FY 2014 generic drug user fee self-identification list, meaning FDA may be forced to adjust next year’s GDUFA fees for more than just inflation.