FDA extends biosimilars deadlines due to US shutdown

Posted On 31 Oct 2013
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As a result of the US government shutdown, the US Food and Drug Administration (FDA) has extended the deadlines and goal dates for its biosimilars activities.



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.

Read the source article at gabionline.net

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