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Reorganization of FDA’s ORA structure

Main aim of US Food and Drug Administration’s is to protect public health. To attain this FDA has to keep an update on new developments in sciences and globalization. Therefore, FDA has set up an alignment programme which helps strengthen the authority. The programme introduces changes in FDA’s Office of Regulatory Affairs (ORA) structure. Program Alignment enables ORA’s workforce to help shape the policies that govern its activities and fully align and integrate with other staff throughout the agency who are doing complementary work within a given product area. Creating distinct product-based and vertically integrated regulatory programs enables the agency to best achieve its objectives, to optimize the coordination and efficiency of the work performed between all FDA centers, directorates and ORA, to strengthen accountability and to reduce duplication. For example One of them, the Office of Pharmaceutical Quality Operations (OPQO) "coordinates, directs, and assists with pharmaceutical product investigative activities" e.g. GMP inspections.


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