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Public Meetings, Workshops, and Webinars

Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation

Pregnant woman craddling her belly

The FDA Office of Women’s Health and the Johns Hopkins Center of Excellence in Regulatory Science and Innovation held a virtual public workshop titled "Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation", on Monday, May 9, 2022.

Learn more about this event on the JH-CERSI webpage and watch the full recording below!

Many chronic and/or pregnancy-related health conditions require the use of medication during pregnancy and lactation. However, few clinical trials enroll pregnant or lactating participants, thus, there is a lack of data on medication safety and efficacy in this population. Through a 3-session virtual workshop, we highlighted the potential role of real-world data to help address these gaps in our knowledge, the opportunities and challenges of collecting real-world data, and current regulatory perspectives on the collection and potential use of real-world data.

 

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