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FDA updates drugs/biologics labeling system

Includes major revisions on pregnancy and breastfeeding, with labeling changes taking effect June 30, 2015. Prescription drugs and biologic products approved after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

On Dec. 3, FDA’s Consumer Healthcare Information announced that women and their health care providers can look forward to getting more useful and up-to-date information over the next few years about the effects of medicines during pregnancy and breastfeeding.

The improvements will replace the current, decades-old labeling system and implement new requirements by FDA regarding labeling information for prescription drugs and biological products. The changes will include major revisions in the subsections about pregnancy and breastfeeding.

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