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

Dec 27th, 2014

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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.

[The story continues for subscribers beginning on page 2, and includes a detailed discussion of ORA’s current challenges and initiatives by its Assistant Commissioner for Operations, Ellen Morrison.  Nonsubscribers can get information on IPQ subscription/licensing and individual story purchasing by contacting Wayne Rhodes ([email protected]).]

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