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Message: Off-label drug use in Canada and the USA

There have been a number of posts unhappy that certain drug combinations or indications were not included in webcast descriptions of proposed clinical trials.  This should not be a concern for two reasons. 

First, Apabetalone has been clearly demonstrated to be remarkably safe, so that removes a barrier to off-label use.

Second, doctors in the USA and Canada have a long history of prescribing drugs off label for indications which have not undergone clinical studies. All that is required is the initial approval by the FDA or Health Canada, then the doors swing open for broad use.  The only down side to off-label use is that it cannot be marketed.

 

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