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.
Introduction to Biotechnology
Law and Regulation
A Program Focusing on Human Biologicals and Drugs
June 5-6, 2008
| The Embassy Suites Washington, D.C. Convention Center Hotel
With the recent enactment of the Food and Drug Administration Amendments Act of 2007 (FDAA Act), learn how the drug industry is being impacted by this legislation. This program can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. By attending this two day program, you will learn the essential elements of the laws and regulations that affect you in the drug industry. From the definition of “drug” to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, this meeting walks you through the major statutory provisions and regulations, and helps you develop a clearer understanding of how they work. Learn More >
FDA’s Proposed Reclassification
of Medical Device Data Systems
(MDDS)
June 10, 2008 | 1:00-2:30 p.m. ET | Audioconference
Almost 20 years after FDA first sought to regulate computer software with a draft policy document, the agency recently initiated a rulemaking to reclassify certain computer- and software-based products. This audioconference will discuss FDA’s proposed rule to reclassify -- from Class III to I -- computer-and software-based products that electronically collect, transfer and store data from medical devices. What is the history of FDA’s regulation of these products? What triggered this FDA action after 20 years? What spurred the proposed reclassification action and what is the agency’s intended outcome? What are the implications for industry, as it continues to develop innovative diagnostic, as well as storage and communication solutions for its customers? Learn More >
Personalized Medicine:
Promises & Challenges
A National Conference Sponsored by the American Association for the Advancement of Science (AAAS) and the Food and Drug Law Institute (FDLI)
June 20, 2008 | AAAS Headquarters | Washington, D.C.
A two-part, national conference offering a high-level roundtable discussion in the morning and a seminar on legal, regulatory and policy issues on personalized medicine in the afternoon. You can attend either session or the entire conference. But space is limited, so register now!
Morning Session 9:00 am - 12 Noon
Anticipating Personalized Medicine: A Roundtable Discussion
Afternoon Session 1:00 pm - 5:00 pm
Implementing Personalized Medicine: A Legal, Regulatory
and Policy Seminar