FDA’s Proposed Rule for Pregnancy and Lactation Labeling: Improving maternal child health through well-informed medicine use

摘要

For the US Food and Drug Administration (FDA), the May 29, 2008 publication of the Proposed Rule for Pregnancy and Lactation Labeling for Human Prescription Drug and Biological Products heralded both an end and a beginning. It marked an end to the labeling initiative process that produced the Proposed Rule and the beginning of FDA’s second-generation approach to labeling drugs and biologics for use during pregnancy, breastfeeding, and the childbearing years. These proposed changes reflect the extensive input and feedback FDA collected from clinicians and experts, and are designed to facilitate informed counseling about and prescribing of medicines for women who are pregnant, breastfeeding, or of childbearing potential.