The perspective article highlights the gaps in clinical drug trials involving lactating women and emphasizes the need for regulatory and research advancements. The study reveals the limited data on drug transfer through breast milk and potential effects on infants, highlighting the historical exclusion of breastfeeding women from trials due to concerns over potential risks to infants. It also discusses regulatory agency steps to address these gaps and the importance of early-stage lactation studies during drug development.

Source: npj Women's Health