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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