Pregnant and lactating individuals have historically been underrepresented in research. However, the COVID-19 pandemic has highlighted the importance of studying these populations to inform the safety, dosing, and effectiveness of products regulated by FDA. The Division of Pediatrics and Maternal Health (DPMH) in the Office of New Drugs also engages in regulatory science research to address challenges related to maternal health issues, especially related to collection of data that can support improved data and communication of pregnancy and lactation data in prescription drug product labeling. Like the work in pediatrics, DPMH in collaboration with internal and external experts, publishes papers in scientific journals that advance areas of important data collection during pregnancy and lactation, with a focus on safety data collection. A primary focus of DPMH’s regulatory science research in maternal health involves research questions to address the optimal communication of risk information in the pregnancy and lactation sections of prescription drug product labeling. Other areas of active interest in DPMH’s maternal health regulatory science research involve use of modeling tools (e.g., physiological based pharmacokinetic modeling) to predict dosing of drugs that may be used during pregnancy, examination of recent trends in drug and supplement utilization during pregnancy and lactation, assessment of drug concentration in breastmilk for certain drugs, understanding neonatal enzyme ontogeny and its influence on drug exposure via breastmilk, and risk management of teratogens.
Additionally, the Office of Surveillance and Epidemiology (OSE) and DPMH have been actively participating in collaborative research to evaluate pregnancy outcomes related to COVID-19 as a collaborator in the COVID-19 Infection and Medicines in Pregnancy (CONSIGN) project established by the European Medicines Agency. OSE is also leading projects to better understand the capabilities of Sentinel’s linked mother-infant data to enhance safety data collection for drugs used during pregnancy.
Maternal Health Regulatory Science Research
Alongside OWH, The Office of New Drugs also engages in regulatory science research to address challenges related to maternal health issues, especially related to collection of data that can support improved data and communication of pregnancy and lactation data in prescription drug product labeling.
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