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What's new
122 result(s) found, displaying 101 to 122
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Australian public assessment report (AusPar)Orserdu monotherapy is indicated for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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PageKey information and updates about the shortage of Creon (pancreatic extract) capsules.
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PageLearn about the AusUDID and how to use it to meet UDI requirements.
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PageRead the latest enhancements and fixes to the Australian UDI Database.
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Medicine shortage alertsSupply constraints will continue until 31 January 2027.
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PageClinical resources and guidance on accessing MDMA and psilocybine under the Authorised Prescriber scheme.
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PageThe following instruments are made under section 47B of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesSix monthly report – supply of unapproved therapeutic goods by a sponsor.
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PageUnderstand and apply the Unique Device Identification (UDI) requirements to your medical devices.
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PageUnderstand the AusUDID Pre-Production environment and how you can use it to ensure compliance with the UDI requirements.
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User guideLearn how to complete an application for consent to import, supply or export medical devices that do not meet UDI-related Essential Principles.
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PageRead about our new compliance principles and our priority focus areas for 2026 and 2027.
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Media releasesWe have expanded our priority focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising, posing potential risks to consumer safety.
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Meeting statementsThe Advisory Committee on Medical Devices (ACMD) convened its 89th meeting on 19 February 2026.
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Meeting statementsThe Advisory Committee on Medical Devices (ACMD) held its 90th meeting on 16 April 2026.
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PageThe Australian UDI Data Dictionary includes a list of the fields in the database, including element names, descriptions, permitted values and other metadata.
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PageRead the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.
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PageThe list of current mesh products supplied in Australia.
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Scheduling decisions (interim)Interim decisions and invitation for comment. Closing date: 10 July 2026.
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PageFind out more about the post-market review we are undertaking on plastic syringes.
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PageResources and technical documents for Machine to Machine (M2M) HL7 SPL users in the Australian Unique Device Identification Database (AusUDID).