FDA and M-CERSI Announce a Two-Day Virtual Public Workshop on Pharmacokinetic Evaluation in Pregnancy

On Monday, May 16, 2022 and Tuesday, May 17, 2022, the FDA/CDER/Division of Pediatrics and Maternal Health in the Office of New Drugs and th

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA and M-CERSI Announce a Two-Day Virtual Public Workshop on Pharmacokinetic Evaluation in Pregnancy   On Monday, May 16, 2022 and Tuesday, May 17, 2022, the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) Division of Pediatrics and Maternal Health in the Office of New Drugs and the Office of Clinical Pharmacology in the Office of Translational Sciences as well as the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will hold a two-day virtual public workshop entitled "Pharmacokinetic Evaluation in Pregnancy." 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. However, 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 pharmacokinetic 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.  Workshop Objectives: Review the general landscape of existing regulatory, scientific, and ethical considerations for drug development in pregnant individuals Describe study design considerations for trials collecting pharmacokinetic data in pregnant individuals Discuss key aspects of utilizing modeling and simulation to inform study design and dosing considerations for pregnant individuals Explore innovative approaches to data generation and analysis in pregnant individuals Date/Time of the Workshop: Date: May 16-17, 2022 Day 1: May 16, 2022, 10:00 am-3:00 pm (ET) Day 2: May 17, 2022, 10:00 am-2:00 pm (ET) This virtual workshop is open to the public; however, registration is required at: https://bioeumd.wufoo.com/forms/modi0au1wjs8as/   Learn More The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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