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BioWorld - Tuesday, December 10, 2019
Home » Topics » Asia-Pacific » Australia

Australia
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Australia's Cogstate out-licenses cognitive assessment tool to Japan's Eisai

September 6, 2019
By Tamra Sami
No Comments
AI-network-machine-learning.png

AI is expected to drive health care effectiveness, increase jobs in Australia

September 4, 2019
By Tamra Sami
No Comments
PERTH, Australia – There is pervasive use of artificial intelligence and machine learning (AI/ML) across the health care industry in Australia, and excitement is building on the opportunities it offers to technologies and ultimately to patients, Ausbiotech CEO Lorraine Chiroiu told BioWorld Asia.
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Australia: No plans to regulate AI, machine learning via separate pathway

August 23, 2019
By Tamra Sami
No Comments
PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Instead, the Therapeutic Goods Administration (TGA) will classify AI and ML under software as a medical device (SaMD) when it is intended for diagnosis, prevention, monitoring or treatment or alleviation of disease.
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Industry supportive of TGA's approach to managing cybersecurity for devices

July 30, 2019
By Tamra Sami
No Comments
PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.
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Aussie Noxopharm announces AU$26M funding facility ahead of planned U.S. Nasdaq listing

July 29, 2019
By Tamra Sami
No Comments
PERTH, Australia – Following positive results across three different oncology clinical trial programs with its lead candidate, Veyonda, Sydney-based Noxopharm Pty Ltd. has secured a AU$26 million (US$18 million) funding facility from U.S. investors leading up to a proposed Nasdaq listing.
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Industry supports most TGA proposals for CDx regs but seeks clarity

July 16, 2019
By Tamra Sami
No Comments
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
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TGA receives mixed response from industry on proposal to begin formal GCP inspections

July 11, 2019
By Tamra Sami
No Comments
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness.
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