US FDA’s OPQ Reshapes For More Nimble Approach To Drug Quality Reviews
Reorganization in January expected to leave CDER’s nine-year-old pharmaceutical quality assessment organization more adaptable to public health emergencies, new pharmaceutical technologies and market dynamics, while further blending approaches to new and generic drug reviews.
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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.
January launch of long-awaited Office of Pharmaceutical Quality is part of broader Center reorganization that also includes new Office of Study Integrity and Surveillance.
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