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FDLI's 20th Annual Advertising & Promotion Conference Official Website Personalized Medicine

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FDLI Press Resource Center
New Press Release Added
June 12, 2008 >>

FDLI, AAAS Host June 20 Conference on Personalized Medicine

FDLI Insighter

   FDLI's Insighter is a column
   that offers a fresh perspective
   on issues affecting the food
   and drug industry.

   May 28, 2008 >>
   Personalized Medicine:
   A Challenging Revolution in    Healthcare


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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.


Better Understanding CMS
Better Understanding CMS and
Its Relationship To FDA
The Regulation of, and Payments for,
Drugs and Medical Devices

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 >





FDLI's Introduction to Drug Law and Regulation
Introduction to Medical Device Law
and Regulation
Understanding How FDA Regulates the
Medical Device Industry


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 >