THE Therapeutic Goods Administration (TGA) has published a comprehensive document clarifying the purpose of Boxed Warnings in Product Information (PI) or Consumer Medicine Information (CMI) documents, along with guidance on how and when to use them.
Boxed Warnings are a risk mitigation measure to highlight special warning statements in the PI and CMI to the prescriber and the public.
They represent one of the most serious types of warnings that can be mandated by a regulatory agency and currently apply to about 30 products on the Australian Register of Therapeutic Goods, the TGA noted.
For more information see the guidance document at tga.gov.au.
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