U.S., Europe Revamp Drug Regulation Pact

Law360, New York (June 19, 2007, 12:00 AM EDT) -- The U.S. Food and Drug Administration, the European Commission, and the European Medicines Agency have updated their cooperative plan for promoting public health in the United States and Europe.

The agencies modified the plan during a conference which began June 14. The plan is an extension of the so-called “confidentiality arrangements,” an agreement for cooperation between the agencies concluded in 2003 and renewed in 2005. According to an FDA press release, the ultimate goal of the arrangements is to “protect public health, reducing regulatory burden and...
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