Abstract

On June 30, 2015, the U.S. Food and Drug Administration implemented the Pregnancy and Lactation Labeling Rule (PLLR). The PLLR was issued to address the shortcomings of pregnancy and lactation information in prescription drug and biological product labeling. The new labeling format under PLLR is structured to better help providers communicate important information about the risks and benefits of taking a specific medication to their pregnant or breastfeeding patients.

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