FDA Hosts Workshop on Tracking Pregnant Women's Drug Use
Published Date: 1/17/2025
Notice
Summary
The FDA is hosting a public workshop on March 27-28, 2025, to make pregnancy registries better and safer for moms-to-be using medicines. This event will bring together experts to tackle challenges and find new ways to study drug safety during pregnancy. Pregnant people, healthcare providers, and drug makers will benefit from improved safety info, with no direct cost but big health impact down the road.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Workshop to Improve Pregnancy Safety Data
The FDA is holding a public workshop on March 27–28, 2025 to discuss how to make pregnancy registries better and safer so we can learn more about drug and biological product safety during pregnancy. The notice says pregnant people, healthcare providers, and drug makers will benefit from improved safety information and that this could have a big health impact down the road.
Push for Multi‑product, Multi‑sponsor Registries
The workshop will discuss using disease-based multi-product, multi-sponsor pregnancy registries to address challenges like low enrollment and long time to study completion. FDA and participants will consider these innovative models as ways to improve the design and conduct of pregnancy registries.
Free In‑Person and Virtual Workshop — Register by March 14
Registration for the workshop is free but you must register online by March 14, 2025, 11:59 p.m. eastern time. The event will be held in person at FDA White Oak Campus (Silver Spring, MD) and streamed virtually via Zoom, and onsite registration may be available starting at 8:30 a.m. on the meeting days if space permits.
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