Availability of Safe and Effective Therapeutic Options to Pregnant and Lactating Individuals Following the US FDA Pregnancy and Lactation Labeling Rule

The United States Food and Drug Administration (FDA) implemented the Pregnancy and Lactation Labeling Rule (PLLR) in 2015, with new requirements for data in prescription drug labeling. Our purpose is to explore the extent and type of pregnancy and lactation data of newly approved prescription drugs and assess if the presented recommendations are data driven.

source https://www.jpeds.com/article/S0022-3476(23)00053-7/fulltext?rss=yes

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