30th June 2022
FDA released 'Safety Considerations for Container Labels and Carton Labelling Design to Minimise Medication Errors' in May 2022.
The purpose of this guidance is to help human prescription drug and biological product sponsors, application holders, and applicants minimise medication errors associated with their products. This guidance focuses on safety aspects of the application holder’s container label and carton labeling design. It provides a set of principles and recommendations for ensuring that critical elements of a product’s container label and carton labeling are designed to promote safe dispensing, administration, and use of the product.