CDER’s Office of Pharmaceutical Quality to reorganize, citing need to address ‘pain points’

The Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ), a super office charged with evaluating the quality of investigational and marketed drugs and biologics, is being reorganized in January 2024 into a new structure in a bid to address ongoing “pain points,” CDER Director Patrizia Cavazzoni wrote in an email to FDA staff today.

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