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FDLI 50th Annual Meeting Heralds New ERA in Healthcare Innovations, FDA Regulations

Is FDA Equipped to Meet Pace of Innovations and a Health Conscious Public?

WASHINGTON, April 30, 2007 /PRNewswire-USNewswire/ -- The Food and Drug Administration (FDA) must adapt to the most significant changes in the history of healthcare, Commissioner Andrew von Eschenbach told attendees at the Food and Drug Law Institute's 50th Annual Conference April 12 in Bethesda, Md.

FDA must find creative "bridging" ways to use its limited financial and personnel resources to deal with the challenges led by scientific breakthroughs increasing health benefits but also risks in foods, drugs and devices, von Eschenbach told the industry representatives, compliance officers, health policymakers, physicians, regulators and attorneys attending the FDLI meeting.

Keynote speaker Sen. Ron Wyden (D-Ore.), sponsor of The Healthy Americans Act -- omnibus legislation to reform the healthcare system in the United States -- said that it was vitally important that Democrats and Republicans work together to enable FDA to improve the drug delivery process. The Healthy Americans Act seeks to provide universal, affordable, quality health coverage to all Americans.

The landmark FDLI conference focused on the impact of scintillating scientific discoveries that are driving technological innovation in health care and the impact of those changes on FDA and pharmaceutical and device manufacturers, as well as the food industry. Industry leaders, including representatives from Siemens and Amgen, provided a glimpse into the future of personalized medicine. Expert panels discussed how these innovations would affect reimbursement, claims, food marketing and safety, clinical research, drug evaluation, radiological health and veterinary medicine. Representatives from all major FDA centers provided inside information on new agency initiatives in these areas.

This 50th FDLI annual meeting also marked a reinvigorated FDLI focus on providing a forum for the constructive development of law needed to keep pace with new technology and its impact on food and drug regulation. "The future of healthcare is rooted in high tech, and FDLI is positioned to facilitate avenues where the regulatory systems can become fast and flexible enough to handle the onslaught of innovation," said Jim Wood, chairman of the Board. "The challenge for science, industry and government will be to collaborate to look for efficiencies which will help enable that solutions can be delivered for the public health, safer and faster -- and FDLI will endeavor to play a catalytic role in that endeavor," added Jim Kelly, president and CEO of FDLI.

PowerPoint presentations by conference faculty can be accessed by visiting http://www.fdli.org/conf/handouts.html. Several plenary speeches will be published in the next issue of the Food and Drug Law Journal.

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.

CONTACT: Michael Levin-Epstein, Editor-in-Chief of FDLI, +1-202-222-0897, mdl@fdli.org

Web site: http://www.fdli.org/

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Posted: May 2007

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