Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary
Clinical Pharmacology & Therapeutics2017Vol. 101(6), pp. 736–744
Citations Over TimeTop 10% of 2017 papers
J Wang, Tamara Johnson, Leyla Şahin, MS Tassinari, PO Anderson, TE Baker, Christina Bucci‐Rechtweg, GJ Burckart, Christina Chambers, TW Hale, D Johnson‐Lyles, Nelson Rm, Christine Nguyen, Denise Pica-Branco, Zhaoxia Ren, Hari Cheryl Sachs, Jason Sauberan, Anne Zajicek, Shinya Ito, LP Yao
Abstract
This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants.
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