FDA/M-CERSI Workshop: Pharmacokinetic Evaluation in Pregnancy
Monday, May 16, 2022
10:00 a.m.-3:00 p.m.
The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled “Pharmacokinetic Evaluation in Pregnancy” on May 16, 2022 and May 17, 2022. The purpose of this workshop is to engage with stakeholders to assess available science and data gaps to advance the conduct of pharmacokinetic (PK) studies in pregnant individuals.
Please join the workshop using the following information:
Most pregnant individuals use prescribed or over-the-counter medications during pregnancy; however, this population has historically been excluded from clinical trials. Therefore, there are important gaps in knowledge about the appropriate dosing for most medications used during pregnancy at the time of approval. In the absence of data, the approved adult dose is typically prescribed to a pregnant individual, but because of the physiologic changes in pregnancy, under dosing or excessive dosing may occur, with potential adverse impacts on safety and efficacy. Further pharmacologic research and collection of PK data during pregnancy are needed to ensure that the appropriate dosing information is available for pregnant individuals. Advancing this field requires identifying key knowledge gaps, barriers to data collection, and potential innovative solutions to improve data generation and analysis.
This workshop is supported by the Food and Drug Administration (FDA) of the
U.S. Department of Health and Human Services (HHS) as part of a financial
assistance award U01FD005946 with 100 percent funded by FDA/HHS. The
contents are those of the author(s) and do not necessarily represent the
official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.