FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products

The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.

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