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U. S. FDA/LeadScope Inc. Sign CRADA For Toxicity Databases


2/8/2006 12:26:38 PM

COLUMBUS, Ohio, Feb. 8 /PRNewswire/ -- The U. S. Food & Drug Administration ("FDA") has signed a Cooperative Research & Development Agreement ("CRADA") with Leadscope, Inc. to distribute toxicity databases compiled using information from the FDA's nonproprietary files. This is the first CRADA for the FDA involving two Centers; 1) the Center for Drug Evaluation and Research ("CDER") and 2) the Center for Food Safety and Nutrition ("CFSAN"). Both Centers will release nonproprietary toxicity information through Leadscope.

The CRADA's objective is to make high quality nonproprietary toxicity data from the FDA's files publicly accessible at very low cost. The databases will be delivered in the new ToxML format, enabling structures and XML data to be deployed together. The databases will be platform independent.

According to Dr. Mitchell Cheeseman (Director, Division of Food Contact Notification, Office of Food Additive Safety) of CFSAN, "This CRADA will enable the FDA to have real-time electronic access to critical data while providing the public with a viable channel to also access and data mine the public information. The nominal fee being charged ($250 per database, per user, per year) will enable us to deliver the data at a low cost to the public, while providing the funding necessary to continually update the databases. None of these will become museum pieces."

Dr. Chihae Yang (Vice President of Toxicology and Predictive Modeling) of Leadscope indicates the initial databases available are the FDA CFSAN 2006 GeneTox, the FDA CDER 2006 GeneTox, and the FDA CDER 2006 Chronic/subchronic. Additional endpoint databases will be released as the data are accumulated. To discuss the content or availability, contact Dr. Chihae Yang of Leadscope at fdadatabases@leadscope.com. For further information concerning the FDA databases go to www.leadscope.com.

Leadscope, Inc.

CONTACT: Dr. Chihae Yang of Leadscope, Inc., +1-614-675-3730, or Fax,+1-614-675-3732, or fdadatabases@leadscope.com



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