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ANDA Backlog Withdrawals May Stimulate Secondary Market By Foreign Firms

Executive Summary

Applications removed from the backlog to avoid GDUFA charge may generate interest from sponsors looking to gain quicker entry into the U.S. market, but work likely would still be required to gain approval.

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ANDA Withdrawals Increase Faster Than Approvals

FY 2016 figure, the highest seen by US FDA under the generic drug user fee program, could be the result of older applications exiting the queue, and may be a sign of progress in dealing with the review backlog.

ANDA Withdrawals Increase Faster Than Approvals

FY 2016 figure, the highest seen by US FDA under the generic drug user fee program, could be the result of older applications exiting the queue, and may be a sign of progress in dealing with the review backlog.

GDUFA Launch Pains: Facility List Fluctuations, Back-Due Backlog Fees

FDA still has backlog fees in arrears more than two months past the payment deadline, but cannot forcibly withdraw the applications; facility listings also change consistently because industry can update them as needed.

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