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Posted by Michael Wonder on 19 Dec 2022

Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency

16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...

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Posted by Michael Wonder on 04 Sep 2019

Health Canada updates its biosimilar fact sheet

4 September 2019 - Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key ...

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Posted by Michael Wonder on 17 Aug 2018

Health Canada proposes ‘pause the clock’ mechanism for pre-market submissions

15 August 2018 - Health Canada recently released for consultation a plan to establish a mechanism that allows for the ...

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