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GDUFA Facility Self-Identification Is Key Element For Speedy ANDA Approval

Executive Summary

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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GDUFA Facility List Lags Last Year, May Be Trailed By Higher Fees

Fewer generic drug facilities have self-identified with the agency than the same time in 2013, perhaps due to their capital situation.

GDUFA Grace Period For Facility Fees Appears To Be Over

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.

GDUFA Facility Fees Likely To Increase Due To Fewer Self-IDs

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.

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