What are the implications of the TGA’s stricter approach to cosmetic treatment promotions? And how might the TGA’s regulatory approach interact with the law of negligence that requires practitioners to warn patients of inherent material risks?

The Therapeutic Goods Administration (TGA) has updated its guidance on advertising cosmetic injectables. What are the implications?

Exa-cel and the FDA review Just last week, on 31 October, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee met to discuss Vertex Pharma’s Biologics License Application for Exagamglogene autotemcel (or exa-cel, and formerly known as CTX-001) — a cell-based gene therapy designed to treat sickle-cell diseases. I have written about exa-cel many times […]

In short, because the texts don’t constitute ‘advertising.’

Australia’s Therapeutic Goods Administration has been more vigilant in policing advertisements for unproven COVID-19 ‘treatments’. But have some slipped through the cracks?

This paper was presented at a conference held on 20–21 February 2012 at The University of Sydney. More details about the event are below.