FDA Seeks to Promote Lactation and Pregnancy Real-World Data Efforts

There is limited information regarding the use of many common medications during pregnancy or lactation. This confusion results in parents overestimating the risks of many otherwise safe medications. In a recent workshop hosted by Johns Hopkins Center of Excellent in Regulatory Science and Innovation (JH-CERSI) and the FDA Office of Women’s Health, speakers discussed FDA guidances related to real-world data (RWD) and drug-pregnancy interactions.

According to Mary Ellen Schneider, “The workshop comes as the FDA has been signaling how it would use RWD in making regulatory decisions. In 2021, the agency issued draft guidance documents on RWD use with clinical registries, RWD use with electronic health records and claims data, and how RWD could be incorporated into clinical study designs (RELATED: FDA issues draft guidance on study design using real-world data, Regulatory Focus 09 December 2021; FDA offers draft guidance for registries as RWD, Regulatory Focus 29 November 2021; FDA issues draft guidance on RWD sourced from EHRs, claims data, Regulatory Focus 29 September 2021).”

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(Source: Regulatory Affairs Professionals Society, May 16^th, 2022)

Tags: HEOR, RWD, RWE, Pregnancy, Lactation