The results of post-marketing pregnancy or breastfeeding safety studies have a limited impact on medication product label advice
Researchers participating in the ConcePTION project have published a landscape analysis of post-marketing pregnancy or breastfeeding safety studies that were registered in the EU PAS Register and on ClinicalTrials.gov. The analysis indicated that, for completed studies, the impact on the label was very low. More information can be found here.
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