BioCentury
ARTICLE | Politics & Policy

FDA to extend biosimilar deadlines due to shutdown

October 19, 2013 12:29 AM UTC

FDA told BioCentury it plans to extend by the number of days the federal government was shut down the deadlines and goal dates for its biosimilars activities, including deadlines for IND meetings with sponsors. Because the biosimilar user fee program was new in FY13, FDA did not have any carryover, or unspent, biosimilar user fees to fund its biosimilars work during the shutdown, which was triggered after Congress failed to pass a full budget or continuing resolution with the start of FY14. FDA did say it still may not meet some biosimilars deadlines because it has to reschedule internal meetings or meetings with sponsors.

FDA did have about $119.7 million in carryover user fees from other user programs and said it does not expect to miss deadlines and goal dates for user fee programs for which it had access to carryover fees during the shutdown, including PDUFA. ...