In Two Days, Four New Drugs Stall at FDA

Reports of four experimental drugs held up at the FDA emerged in the first two days of this week. “There’s almost certainly a bit of coincidence at work here, but it also seems to be one more sign of the tough safety climate at the agency these days.” Below are the 4 drugs. No doubt the FDA is looking seriously at the side effects and studies and the new Sentinel system once it is up and running will be a big help for having additional data. BD

Milnacipran

Asenapine

Fablyn

Vicodin

In other FDA news the Government Accountability Office is looking in to the Ranbaxy case, stating there were too many oversights and asking why this occurred. I might guess part of the issue was due to a lack of technology for reporting purposes, which now the task is being undertaken to bring the FDA up to current standards to have the intelligence to stay on top of such. BD

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