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Behind every successful New Drug Application is an effective relationship involving representatives of the pharmaceutical industry and the U.S. Food and Drug Administration. Across the pharmaceutical industry, both small and large organizations place responsibility for oversight of FDA interactions within Regulatory Affairs.
This study examines what Regulatory Affairs organizational structure works best for interacting with the FDA and how the Regulatory function should lead interactions with the FDA. Additionally, this research explores how some organizations have found success in using a Rockville satellite office as a bridge to building lasting FDA relationships and providing insights on emerging regulatory issues.
Regulatory leaders can use the insights from this research to compare and adjust their group’s structure and how their Regulatory function leads FDA interactions.