PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has initiated proceedings in the Federal Court of Australia against Medtronic Australasia Pty Ltd. for alleged unlawful supply of its Infuse bone graft kit, which contains a medicine and other components to stimulate bone growth in patients.

PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.

PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of devices currently on the market, and these devices will need to be re-registered if they are to stay on the market.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has cleared Speedx Pty Ltd.’s PlexPCR SARS-CoV-2 test, which detects all current circulating variants of the SARS-CoV-2 virus at a time when most of the country is in lockdown as the delta variant circulates.

PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is proposing refinements to the regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin.

PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.

PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.

PERTH, Australia – After unveiling its new regulatory framework for custom-made and 3D-printed devices, Australia’s Therapeutic Goods Administration (TGA) is now proposing further refinements due to pushbacks from stakeholder that manufacture custom-made and patient-matched devices.