FDA action on medication labeling information

By Dr Nicola Davies

Labeling information, including product inserts, are important components of marketed drug products. Clear and complete labeling information is critical for both health professionals and patients to make informed decisions. It also ensures consumers are aware of the correct use of these medications to maintain safety and achieve the intended effectiveness. The importance of appropriate labeling information is highlighted by the US Food and Drug Administration’s recent actions to optimize labeling content for prescription drugs, including biologicals.

Action by the FDA