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PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and clinical decision support software.
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic.
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic.
PERTH, Australia – Molecular diagnostic company Speedx Pty Ltd. has invested in a Perth-based startup that makes the raw materials needed for polymerase chain reaction (PCR) COVID-19 tests. The two companies will work to develop a new at-home rapid PCR test to ensure Australia can become self-sufficient with producing PCR tests. A rapid PCR test that gives an accurate result in minutes could be used at home or work.
PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product.
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”
PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product.
Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).
PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.
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