Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown.
Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown.
Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that have fees attached” – including NDAs – “will be accepted for 2014 until the date of enactment of a [fiscal year] 2014 appropriation or a Continuing Resolution.” King did not respond to the question of whether products already accepted for FDA review would face potential delays as a result of the shutdown.
While FDA awaits a budget appropriation or continuing resolution, it will be limited to the following tasks, according to an official statement:
As described in a Department of Health and Human Services (HHS) contingency plan for the shutdown, FDA will be “unable to support the majority of its food safety, nutrition, and cosmetics activities. FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.”
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