Health Canada seeks feedback on Consideration for Inclusion of Women in Clinical Trials and Analysis of Data by Sex

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Health Canada is seeking comments and suggestions on its recently revised guidance document: Consideration for Inclusion of Women in Clinical Trials and Analysis of Data by Sex. 

This document has been developed to address the following:

• To clarify the scope of the original guidance, including the populations to which it applies;
• To provide further guidance to sponsors on issues not addressed or minimally addressed in the 1997 guidance document. These include: inadvertent pregnancy in the course of a clinical trial and inclusion of pregnant and breastfeeding women in clinical studies/trials;
• To support and encourage good therapeutic product development practices, including new approaches and methodologies, to identify and analyze potential sex differences across the product life cycle;
• To provide guidance within the current regulatory environment.

Interested parties are encouraged to provide comments and suggestions by April 16, 2012.

Read more about this document, and about how you can submit your input, on Health Canada’s website.