THE Therapeutic Goods Administration has published submissions received during a consultation earlier this year on guidance around Boxed Warnings.
There are over 30 products on the Australian Register of Therapeutic Goods currently carrying Boxed Warnings, with most of the submissions giving strong support for the proposed guidance, although with some modifications.
Main concerns around the proposal related to what evidence is required to implement the warning notice, how and when it is required in both the PI and the CMI, how it is to be communicated in advertising and more.
Respondents included consumer groups, NPS MedicineWise, the SHPA and more - tga.gov.au.
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