Biotech Negotiates Successfully at FDA Business Issue The Regulatory Affairs Department at one of the largest and most successful biotechnology companies in the world faced a multitude of negotiation challenges. Regulatory Affairs staff were charged with coordinating the activities of cross-functional teams that research and develop therapeutics, test them, and usher them through the rigorous FDA approval process. Product Development teams routinely unite individuals with a multitude of differing backgrounds including science, sales and marketing, biostatistics, clinical, legal and other perspectives to create a product and process that will meet FDA requirements. In addition, they must negotiate with the FDA itself to create a process that meets the FDA's interests in protecting public he

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