Canada Updates Guidance on Women in Clinical Trials

An updated Health Canada guidance provides advice on when to include or exclude women from device and drug trials, including women who are pregnant or breastfeeding. Women, including those of child-bearing potential and post-menopausal women, should be included at the earliest stages of clinical trial research so that potential sex-related differences are identified and taken into consideration when planning Phase III trials, the Jan. 9 guidance states. It supersedes 1997 guidance on the same topic.
International Medical Device Regulatory Monitor