Tag: Clinical Trials
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Navigating the ‘regulatory quagmire’ for extracellular vesicle therapies in Australia
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.
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Two years on from Australia’s bold psychedelic experiment, here are our concerns
While a new Melbourne trial finds psilocybin-assisted therapy beneficial for the mental health of terminally ill patients, Australia’s broader experiment with medical psychedelics faces challenges. Our analysis raises concerns over a patchwork of regulations, unlawful promotion, and the potential for patient harm, and urging improvements to the authorised prescriber scheme.
Sydney Health Law 