Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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When using the extended addendum workflow in impax 6.5.X and above with embedded reporting there is potential for loss of report text when validating addendums. this occurs when all of the conditions listed below happen at the same time: - the dictation or report text is not started as intended at the initial cursor location and - the keyboard arrow keys mouse or speechmike input are used to move the cursor in the addendum before dictating or typing report text and - the "reportstatus" bookmark is used to automatically add the status to the addendum and - with respect to impax 6.5.4 and prior 6.5.X versions the "beginprotect" and "endprotect" bookmarks have not been used to protect the "reportstatus" bookmark. if all of the above conditions are met and the cursor is placed at the "reportstatus" bookmark location when starting to dictate or type report text impax will overwrite the text entered at the "reportstatus" bookmark location with the addendum status when the addendum is validated. as a result some of the text of the addendum is not saved in the validated addendum.