The US Food and Drug Administration (FDA) has finalized its guidance on dose banding to assist sponsors in labeling ready-to-use containers for injectable drug products. With this guidance, FDA aims to eliminate drug waste from single-dose vials by shifting toward exact weight or body surface area-based doses.
The final guidance, which was published on 2 October 2023, is intended for sponsors seeking to update the labeling information in a supplement to an existing new drug application (NDA) or biologics license application (BLA) or for new NDAs and BLAs.
Dose banding refers to dosing based on weight or body surface area (BSA), drug products that are available in a range of strengths in ready-to-use containers, or instances in which the entire drug content of the ready-to-use container is intended to be administered to a patient…
