With hope for congressional compromise waning by the hour, the federal government is bracing for its first shutdown in 17 years, and for the FDA, that means furloughing about half its staff and ditching duties it can no longer afford. What that spells for drug developers with eyes on approval, however, remains murky.
If the government shuts down come Tuesday, the FDA will lose 6,620 employees, about 45% of its staff, and the agency would have to cease many inspections, enforcement actions and monitoring operations, also suspending the "majority" of its internal lab research, according to a Department of Health and Human Services briefing.
As for advisory panels, PDUFA dates and the agency services that affect the drug development world, things are more opaque. While the government is quite clear that only mission-critical, life-and-death work will
continue, DHHS also said that the "FDA would continue limited activities related to its user-fee funded programs," which would include drug approvals.
Read more: What happens to the FDA in a government shutdown? - FierceBiotech http://www.fiercebiotech.com/story/what-happens-fda-government-shutdown/2013-09-30#ixzz2gRSKPWls
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