FDA Field Operation 2015 Priorities Include Alignment with Centers and Lab Optimization

Top priorities for FDA’s Office of Regulatory Affairs (ORA) in 2015 include closer functional alignment with the agency’s reviewing centers and a major restructuring and optimization of its laboratory operations.

Among the areas that ORA will be focusing on as part of the center/field “program alignment” initiative are: ● new inspection protocols ● joint training with the centers, and ● staffing and management models.

The “lab optimization” project and the changes in lab management structure will result in all 13 field labs reporting through a single “science executive” who will be located at ORA headquarters.

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