Extracellular vesicles are generating excitement as tools for regenerative medicine and drug delivery — but no EV-based therapeutic has received market approval anywhere in the world. In a new Perspective article, we argue the barriers are not solely technical. They are also regulatory.

The most recent two issues of the Journal of Law and Medicine carry articles authored or co-authored by me. The first is lead-authored by Mike O’Connor (with me and Cameron Stewart) and is titled ‘Sexual Boundary Violations by Doctors – Context, Regulatory Consequences and Preventive Strategies’ (see PMID 38761390). In that paper, we discuss the […]

A genome-edited pig kidney I was pleased to be invited to reflect on the future of xenotransplantation and human genome editing recently in an interview on ABC’s The World with Beverley O’Connor. The interview was broadcast following news of the unfortunate passing of Richard “Rick” Slayman — the first human to have received a genome-edited […]

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

Fidge v Pfizer is notable for making several provisional holdings. Among those was Rofe J’s holding that it is not a ‘necessary incident of medical practice’ for doctors to challenge government decisions based on alleged breaches of legislation, even when done in a purported attempt to protect patients’ health.