FDAnews Drug Daily Bulletin

FDA, SWEDEN ENTER INTO CONFIDENTIALITY AGREEMENT

May 9, 2006
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The FDA and Sweden's Medical Products Agency (MPA) have entered into a confidentiality arrangement allowing them to exchange certain types of information not available publicly.

The FDA said the arrangement will help in "sharing drug safety data potentially resulting in regulatory measures we want to implement globally in a concerted manner." The arrangement also helps eliminate the problem created by the time difference between North America and Europe when attempting simultaneous risk communications.

The kinds of information to be shared include law enforcement and internal pre-decisional information.