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Food and Drug Law Institute Sponsors Colloquium on Communicating Risk/Safety Drug Information
Date:11/26/2007

Landmark Meeting Dec. 6, 2007 to Address FDA's Next Big Challenge

Is the Food and Drug Administration Effectively Communicating Risk/Safety Information on Drugs and Devices to Physicians and the Public?

WASHINGTON, Nov. 26 /PRNewswire-USNewswire/ -- In 2005, FDA banned the use of a device that repairs damaged cells and treats cancer through electromagnetic waves, known as the Pap-Ion Magnetic Inductor (PAP-IMI), because of its apparent connection to patient injuries and death. However, on November 19, 2007 The Seattle Times reported that the PAP-IMI is still in use in at least five states, and that FDA has yet to issue a public statement about the risks linked with the device.

FDA's task is indeed daunting. A panel of experts will discuss and debate the issue of risk communication at a landmark colloquium, Communicating Risk/Safety Information: How FDA Is Meeting the Challenge, sponsored by the Food and Drug Law Institute (FDLI), Dec. 6, 2007, in Washington, D.C.

This meeting is the third in a series of colloquia sponsored by FDLI. Under its new strategic direction, FDLI is committed to using the colloquium series as a neutral forum to address the legal, regulatory, policy and practical implications of technological innovations affecting the food and drug industry.

As the public becomes more concerned about whether it's safe to take --- or stop taking --- their medications, FDA is making risk communication a top priority. The agency has formed an advisory committee on communication and implementing new Congressional requirements on risk evaluation. This program seeks to clarify what that means for those who must deal with adverse events and contraindications every day.

Colloquium attendees will receive:

-- Results of a study on how FDA handled the antidepressant drug controversy;

-- Analysis of the new risk evaluation and mitigation strategy (REMS) requirements;

-- Tips on developing
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SOURCE Food & Drug Law Institute
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