www.fdanews.com/articles/168699-cder-secures-approval-for-new-quality-super-office
CDER Secures Approval for New Quality ‘Super Office’
November 24, 2014
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.”
Drug GMP Report