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What's new
76 result(s) found, displaying 26 to 50
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News articlesWe are seeking feedback on our proposal to improve information sharing about the safety, quality, and performance of medical devices.
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PageRead about court actions. It is our practice to publish details of regulatory compliance decisions and actions on our website.
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Media releasesTwo Victorian residents have been charged with additional offences following an Australian Border Force led investigation into the alleged importation of Performance and Image Enhancing Drugs into Australia.
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GuidanceGuidance providing an overview of the legislative framework for listed medicines and assessed listed medicines.
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ConsultationWe are seeking public comment on issues and proposed amendments to the Permissible Indications Determination.
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Prescription medicine decision summaryExdensur (depemokimab) has been approved as an add-on maintenance treatment for severe asthma in adults and adolescents with eosinophilic airways inflammation, and for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.
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GuidanceThis guidance is to assist sponsors in fulfilling the regulatory obligations necessary to ensure that any representations made about their listed medicine(s) comply with the requirements of the Therapeutic Goods Act 1989.
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DatasetSearch registrations for new medicines including generic medicines, chemical and biological entities (NCE and NBE), biosimilar medicines, biologicals and combinations. This includes extensions of indications, which describes new uses of medicines.
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DatasetSearch applications for new medicines, or new uses for existing medicines, that are under current evaluation.
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Media releasesThe Therapeutic Goods Administration (TGA) is aware of media reports about the safety of defibrillator devices used in some ambulance services and healthcare facilities.
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Advertising permissionApproval under section 42DF for use of restricted representations by Boston Scientific Pty Ltd
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PageApproved COVID-19 home use self-tests for supply in Australia
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Media releasesAs part of a coordinated enforcement action, 4 search warrants were simultaneously executed at 2 retail premises in Kippax, a retail premises in Belconnen, and a residence in north Canberra.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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DatasetSearch approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages.
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PageRead the latest enhancements and fixes to the Australian UDI Database.
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PageHow to report a side effect, reaction or other problem with a therapeutic good. Your report can help keep others safe.
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PageLearn how to add sponsor information to UDI records using the Australian UDI sponsor link template.
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PageThe TGA has a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
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PageLearn about GCP inspections of clinical trial sites of investigational biologicals, medicines and medical devices.
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Media releasesWe have commenced proceedings in the Federal Court of Australia against Better Leaf Pty Ltd (Better Leaf), Better Life Aussie Pty Ltd (Better Life), and their sole director for the alleged unlawful advertising of medicinal cannabis.
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GuidanceGuidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods.
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PageRead the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.
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TransactionIf you can’t find the information you need in our guidance, make an enquiry through our online portal.