Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.
Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach.
Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted medical devices.
Australia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over sound abatement foam used in CPAP machines marketed under the Respironics brand.
Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
Australia’s Therapeutic Goods Administration floated a draft rule on risk classification for in vitro diagnostics, which does not apply to home use tests, the subject of impending rulemaking.
A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe altogether.
Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.
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