FDA to continue pre-shutdown reviews

FDA said it will continue to review applications submitted prior to the government shutdown and may issue new approvals. However, the agency will stop accepting new NDAs and BLAs. Advisory committees discussing specific drugs will meet as scheduled, according to a spokesperson.

The agency will use carryover or unspent user fees to continue to review drug and biologics applications filed prior to Oct. 1. Of 14,779 FDA employees, 8,180 will continue working, including 6,043 supported by user fees. The agency stated that it cannot accept or spend any new user fees until Congress enacts FY 2014 appropriations legislation. ...