THE European Medicines Agency has released a guideline for public consultation providing recommendations on how to include and/or retain pregnant and breastfeeding people in clinical trials.
If adopted, it will mark a change in paradigm in the development of medicines in pregnancy and breastfeeding, which generally excludes pregnant and breastfeeding people from clinical trials, leaving the safety of these medicines unknown.
The guideline suggests these groups should be considered for all medicines intended for people who can potentially give birth to children, and lays out the principles and conditions that should be met to ensure the safety of clinical trial participants, as well as their fetuses and babies.
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