Susan Sheldon, Ph.D.

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.

FDA Inspections Webinar with Recent Trends in Observations

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EAS has posted our latest webinar to the On-Demand webinars page. Presented by Sophia Lily, Preparing for FDA Inspections, is free to view on-demand – along with numerous other webinars presented by our consultants on a variety of topics. EAS regulatory webinars provide timely and relevant content to help your firm take actionable steps to understanding FDA requirements.

Hemp and CBD Regulatory Fact Sheet

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