Opportunities and Challenges to Leveraging Real-World Data for Post-Market Safety Studies in Pregnancy and Lactation: Meeting Proceedings

Abstract

This proceeding summarizes a meeting hosted by the Reagan-Udall Foundation for the Food and Drug Administration (FDA) (FDA Foundation) to understand the current use of and evidence for approaches that leverage real-world data (RWD) sources beyond registries to assess post-market drug safety studies in pregnant and lactating persons. Participants represented a wide breadth of expertise, including drug manufacturers, regulators, academic researchers, and health care providers and insurers. Participants reviewed the state of the science and developed solutions to advance the use of RWD to address limitations posed by traditional product registries, such as long timeframes and single-arm study design.