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  • Australia’s TGA Launches Database of Adverse Event Notifications

    Australia's Therapeutic Goods Administration has launched a new Database of Adverse Event Notifications (DAEN), an online resource that will provide the public and the health care community with access to adverse event reports. The database, which will be updated monthly, includes reports from January 1971 up until three months prior to the date of access to allow the agency to investigate new reports.   The database currently contains around 251,000 reports...
  • Regulatory Transparency Measures Lead to False Alarms

    What happens when regulatory databases are made easier to access and understand? In at least one instance of irony, just the opposite of what might be expected. Australia's Therapeutic Goods Administration (TGA) on 1 August 2012 sent out a media advisory after receiving what it said were reports of a news story indicating influenza vaccines were unsafe. Quite the contrary, said TGA. "In fact, there have been no recorded deaths from influenza vaccine in Australia," regu...