The deadlines and goal dates, which include deadlines for Investigational New Drug (IND) meetings with sponsors will be extended by the number of days that the federal government was shut down, i.e. 16 days.

Because the biosimilar user fee programme was new in fiscal year 2013, FDA did not have any carryover, or unspent, biosimilar user fees to fund its biosimilars work during the shutdown, which was triggered after US Congress failed to pass a full budget or continuing resolution with the start of fiscal year 2014. FDA may miss some goal dates associated with the biosimilars user fee programme, which was the only user fee programme halted during the 16-day government shutdown.

Despite the extension, FDA also stated that it still may not meet some biosimilars deadlines because of the need to reschedule certain internal meetings or meetings with product sponsors.

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