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Tag Archives: Literature Based Submissions

2015 ARCS Scientific Congress: Literature based submissions

One of our Regulatory Consultants, Megan Polidano, attended the 2015 ARCS Scientific Congress session ‘LBS – the options and lessons’ this week. Here is her summary. The ARCS session on literature based submissions (LBS) provided an overview of the Australian … Continue reading

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A summary of the TGA’s Literature Based Submission changes

The Therapeutic Goods Administration has updated their ‘points to consider’ publication (dated 2003) regarding the submission of literature-based data in support of prescription and OTC medicine registration in Australia. It is important that anyone wishing to pursue a Literature Based Submission … Continue reading

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