Welcome to FDLI
The Food and Drug Law Institute is committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.
November 18-19 | The Madison Hotel | Washington, DC
The Food & Drug Administration (FDA) has been and remains the focus of all new drug and medical device approvals and post-approval monitoring of existing healthcare products and technologies. However, this agency no longer rules alone. Given the heightened focus on economic considerations, a sleeping giant has awakened! The Centers for Medicare and Medicaid Services (CMS) impact all decisions regarding drug development, clinical trials, and post-approval uses and reimbursements. Learn More >
November 6-7 | L’Enfant Plaza Hotel | Washington, DC
Through a blend of presentations and active learning opportunities, you will learn the essential elements of medical device regulations in a systematic and comprehensive way. The first day will focus on the legal framework, FDA’s organization and pre-market requirements and the second day will focus on postmarket requirements, the Quality System Regulation (QSR), adverse events, and promotion and advertising. The program will walk you through key regulations and policies, while it helps you develop a clearer understanding of how they work. You’ll receive an overview of the FDA regulatory structure, obtain pointers on how to prepare a successful 510(k) submission, and learn about new and developing FDA policies and procedures affecting all phases of medical device regulation. This program will help you to think like a seasoned medical device professional. Learn More >