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FDA Expands OPEQ ‘Super Office’; Splits In Vitro Diagnostics, Radiological Health Office In Two

 
• By Shawn M. Schmitt

The US agency’s Office of Product Evaluation and Quality also created new divisions in its Office of Regulatory Programs and Office of Clinical Evidence and Analysis.

Entrance to FDA headquarters in Maryland
• Source: Alamy

The US Food and Drug Administration’s Office of In Vitro Diagnostics and Radiological Health – which operates under the umbrella of the agency’s Office of Product Evaluation and Quality (OPEQ) – has been split in two, the FDA announced on 2 May.

The result is the Office of In Vitro Diagnostics (OHT7) and the Office of Radiological Health (OHT8). “The new structure will provide focused executive leadership and better meet...

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