Novartis To Monitor FDA Success In Meeting User Fee Goals During CDER Move
This article was originally published in The Pink Sheet Daily
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CDER Move To White Oak Site Delayed Until July
The move, which had been scheduled for April, has been pushed back because the building is not ready, FDA says. The CDER reorganization is also being delayed to coincide with the move.
FDA Reorganization Of New Drug Office Would Split Neuropharmaceutical Division
Neurology and psychiatry drugs would be reviewed in separate divisions under the proposed restructuring. The reorganization, which aims to group products by therapeutic indications and integrate the review of biologics and drugs, would eliminate ODE V.
Able Unable To Reform On Its Own? Firm Seeks Consent Decree To Address Manufacturing Issues
“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.