FDA Pharmaceutical Quality Office Launches With Team-based Reviews

CDER’s ‘super office’ aims to transform how industry thinks about manufacturing, but still needs to hire management and other staff.

FDA’s Office of Pharmaceutical Quality is now officially up and running, although one of the tenets of the reorganization, its new integrated review of applications, has been in place for a few months.

After two years of preparation and waiting, the agency announced Jan. 12 that OPQ had officially launched. The “super office”...

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