Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for Comments

摘要

The Food and Drug Administration (FDA) is announcing a public workshop entitled "Evaluation of the Safety of Drugs and Biological Products used during Lactation." The purpose of this workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data, to inform of the potential risks of medication use during lactation, and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation.