FDA issues long-awaited plan for electronic labeling

After extensive industry debate, FDA development and a GAO study weighing the pros and cons, FDA has proposed a new rule requiring electronic labeling.

The rule applies to the package insert, or PI, typically provided with drug packaging for the benefit of HCPs. Pharma companies would be required to provide the PI in an electronic file and no longer permitted to distribute it in paper form with the packages.

A big upside to electronic labels is the ability to ensure that labeling reflects the most up-to-date safety risks. While Med Guides and other literature aimed at patients (including promotional labeling) are excluded from the requirement, opponents argue that many patients rely on paper PIs to get critical drug information.


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