FDA Furlough Freezes FY14 Filings; ‘Emergency’ Tasks Take Precedence

With Congress unable to agree on a fiscal 2014 government-funding plan, the FDA has largely limited its operations to “emergency work” and enforcement activities — strictures that have forced the agency to freeze regulatory submissions for fiscal 2014 supported by new user fees. In a notice to industry Tuesday, the FDA said the government shutdown has restricted non-essential activities to those that are funded by “carryover user fee balances” under PDUFA and GDUFA.
Drug Industry Daily