Drugs

Workshop on Improving Pregnancy Drug Safety Registries

FDA has announced a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the safety of drugs and biologics during pregnancy. The 5/7-8 workshop is part of a broader effort to strengthen the generation of high-quality human safety data for medications used during pregnancy, an area that has historically faced significant data gaps, according to the agency.

Pregnancy registries, which track health outcomes in pregnant patients exposed to specific drugs or biologics, are a key tool for postmarket safety surveillance. However, FDA notes ongoing challenges in designing and implementing these registries, including difficulties with patient enrollment, data completeness, and long-term follow-up.

The workshop will bring together stakeholders from across the healthcare ecosystem — including regulators, academic researchers, pharmaceutical companies, healthcare providers, and patients — to explore potential solutions.

Planned discussions will focus on the current state of pregnancy registries, barriers to collecting reliable safety data, and strategies to improve registry design and execution. Participants will also examine more innovative models, such as disease-based registries that include multiple products and sponsors, as well as coordinated registry networks.

FDA says input from the meeting could help inform future regulatory and scientific approaches to better evaluate the safety of medical products used during pregnancy.

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