Article

Call to Action: Harmonisation of Pharmacovigilance Regulations for Post-marketing Pregnancy and Breastfeeding Safety Studies

2022-12-09

Abstract excerpt

Globally, more than 200 million women become pregnant each year, most of whom receive medications despite limited information on their safe use during pregnancy. The paucity of drug safety data on pregnant and breastfeeding women stems from the routine exclusion of this population from clinical trials due to scientific, ethical, regulatory and legal concerns. Consequently, at the time of initial drug approval, the...

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Literature Corpus work: dcdca054-a11d-577f-8f07-2f9a1dd0054c
DOI: 10.22541/au.167061286.68506279/v1

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