FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs

The US Food and Drug Administration (FDA) "may require” or seek agreement from sponsors to conduct post-marketing studies to analyze long term effects of breast cancer drugs in both pre- and post-menopausal women in a final guidance issued on 17 June. The guidance also provides other considerations for sponsors as they plan for the inclusion of premenopausal women in clinical trials of drugs for breast cancer treatment.