Lawbalization Episode 30: Navigating FDA Regulation in Life Sciences: Compliance, Enforcement, and Product Strategy with Seth Olson
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全集摘要
Jonathan Bench speaks with Seth Olson, an FDA regulatory attorney at Kirton McConkie, about navigating the complex and often misunderstood world of FDA regulation across the life sciences industry. Seth shares how his experience inside the FDA and in private practice shapes his approach to advising companies on compliance, enforcement, and product strategy throughout the full product lifecycle. They discuss common misconceptions about the FDA’s role, how companies should think about regulatory “gray areas,” and what separates organizations that successfully respond to inspections and warning letters from those that struggle. The conversation also explores emerging challenges in areas like laboratory-developed tests and biologics, the role of risk tolerance in regulatory decision-making, and how FDA considerations can impact transactions, innovation, and long-term business success. Connect with Seth on LinkedIn 这里.