Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
The difficulties in rolling out the EU’s Medical Device Regulation are well known, but the attendant delays continue to exert ripple effects in other markets. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has formally extended the time frame for acceptance of existing CE marked devices into the U.K. market, another demonstration of the ongoing turmoil associated with the herky-jerky deployment of the MDR.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore.
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore. That’s the problem patients are facing with Novo Nordisk A/S’ semaglutide products, Ozempic and Wegovy, which have been in short supply all over the world since early last year due to significant, and unexpected, demand for weight management.
Mabwell (Shanghai) Bioscience Co. Ltd. has received approval of its IND application from Australia's Therapeutic Goods Administration (TGA) for 9MW3811 injection for tumors and pulmonary fibrosis.
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