Sousan Sheldon, Ph.D. is a former FDA International Policy Analyst for medical devices and pharmaceuticals with expertise in Asia, the Middle East and Canada. She is an expert in regulatory pathways for INDs, NDAs, ANDAs, 510(k)s, IDEs, De Novo, HDE, PMAs, and other regulatory submissions and has extensive knowledge in the development of medical devices, medical devices containing antimicrobial agents, combination products, companion diagnostic products, and applications for Clinical Laboratory Improvement Amendment waivers. She has a doctoral degree in Microbiology/Immunology from the University of North Texas.
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