FDA’s New ‘Super Office’ Attacks Pharmaceutical Quality Risks

Launched this month, CDER’s OPQ ‘Super Office’ blends the agency’s CMC review programs for new and generic drugs together, and focuses them on significant risks like the difficulty of release-testing modified-release drugs.

FDA’s Center for Drug Evaluation and Research Jan. 11 launched its Office of Pharmaceutical Quality in a bid to put quality on an equal footing with safety and efficacy in the agency’s process for reviewing and approving drug products.

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