Two Sweeping FDA Reorganizations Change Inspection, Review Activities

Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments.

In the “biggest reorganization in the history of the FDA,” according to Commissioner Robert Califf, the agency’s Office of Regulatory Affairs (ORA), which oversees inspections and compliance for all regulated products, will shift compliance officers and field investigators into individual drug, device and food center operations.

The new Office of Inspections and Investigations will focus on a narrower core mission — conducting inspections, investigations and import oversight — and will streamline and reduce duplication by developing an agencywide workflow management platform for the process of requesting and planning inspections.

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