Navigating FDA Regulatory Process: Essentials for Entering the US Market

Amy Fowler – Attorney, Pathmaker FDA Law

Amy Fowler, Esquire, FRAPS, RAC, is the President and Founder of Pathmaker FDA Law. She brings over 30 years of experience guiding medical devices and pharmaceuticals to market through the maze of regulations. She counsels clients on regulatory strategies and is an expert with submissions and other legal topics related to medtech products and has been on the adjunct faculty for many years, teaching Masters’ Level student on various regulatory legal topics.

🔗 Connect with Amy: https://www.linkedin.com/in/amy-fowler-rac-fraps-esquire-6a412a1b/

Theo Thompson – Attorney, Pathmaker FDA Law

Theo Thompson, J.D., LL.M., CIPP-US, helps organizations navigate the complex regulatory landscape that stands between innovation and impact. As an FDA regulatory attorney at Pathmaker FDA Law, he specializes in medical device, pharmaceutical, and privacy law—working with organizations ranging from Fortune 5 companies to pre-revenue startups to bring life-changing…