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MIL-OSI Australia: Special Access Scheme online system

By   /  July 30, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Special Access Scheme online system

Source: Australian Therapeutic Goods Administration On Monday 30 July 2018, an online system was introduced to enable the electronic submission of SAS applications and notifications to the TGA. Use of this online system will reduce administrative burden on health practitioners and provide users with additional system benefits to manage their SAS applications and notifications. Please […]

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MIL-OSI Australia: ACV meeting statement, Meeting 8, 30 May 2018

By   /  July 24, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, law, Legal, MIL OSI, Open Source Intel, Pacific Region, Technology, Trade  /  Comments Off on MIL-OSI Australia: ACV meeting statement, Meeting 8, 30 May 2018

Source: Australian Therapeutic Goods Administration Advisory Committee on Vaccines Section A: Submissions for registration The committee’s advice was sought on one application, to register a new vaccine. The committee provided advice on a range of issues. Further details of the ACV discussion and advice associated with this pre-market item will be released within the Australian […]

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MIL-OSI Australia: Intragastric balloon systems

By   /  July 18, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Exploration, Gas, Health, Inflation, MIL OSI, Open Source Intel, Pacific Region, Trade, United States of America  /  Comments Off on MIL-OSI Australia: Intragastric balloon systems

Source: Australian Therapeutic Goods Administration TGA product safety review The TGA has conducted a product safety review of two intragastric balloon systems included on the Australian Register of Therapeutic Goods (ARTG). The TGA’s review follows information published by the USA Food and Drug Administration (FDA) about deaths and serious injuries to patients associated with use […]

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MIL-OSI Australia: TGA business portals scheduled maintenance, 27-29 July 2018

By   /  July 17, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, Business, Commerce, English, Health, MIL OSI, Open Source Intel, Pacific Region, Trade  /  Comments Off on MIL-OSI Australia: TGA business portals scheduled maintenance, 27-29 July 2018

Source: Australian Therapeutic Goods Administration The following Therapeutic Goods Administration (TGA) websites and Business Portals will be undergoing scheduled maintenance between 5:00pm AEST Friday 27 July 2018 and 5:00pm AEST Sunday 29 July 2018. During this time there will be intermittent outages to all TGA portals. If you have any questions or need more information […]

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MIL-OSI Australia: TGA presentations: The new Code – where are we at? 12 & 13 June 2018

By   /  July 12, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, law, Legal, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: TGA presentations: The new Code – where are we at? 12 & 13 June 2018

Source: Australian Therapeutic Goods Administration Update on the implementation of the new Therapeutic Goods Advertising Code and complaints system. Sessions Disclaimer These presentation papers are provided on the TGA’s website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers […]

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MIL-OSI Australia: Advertising hub

By   /  July 1, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, Education, English, Health, law, Legal, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Advertising hub

Source: Australian Therapeutic Goods Administration The advertising hub brings together news and information about the regulation of therapeutic goods advertising. It contains tools for both consumers and advertisers, including fact sheets, e-learning modules and forms for reporting illegal advertising and submitting enquiries. It also provides information about the changes to the framework for advertising therapeutic […]

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MIL-OSI Australia: ACV meeting statement, Meeting 7, 28 March 2018

By   /  June 29, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: ACV meeting statement, Meeting 7, 28 March 2018

Source: Australian Therapeutic Goods Administration Advisory Committee on Vaccines Section A: Submissions for registration The committee’s advice was sought on one application, to extend the indications for the vaccine. The committee provided advice on a range of issues. Further details of the ACV discussion and advice associated with this pre-market item will be released within […]

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MIL-OSI Australia: Medicines Safety Update, Volume 9, Number 2, June 2018

By   /  June 29, 2018  /  24-7, Asia, Asia Pacific, Asia Pacific Region, Australia, Australian Capital Territory, Australian Therapeutic Goods Administration, Canada, Education, English, Exploration, Gas, Health, MIL OSI, New Zealand, Open Source Intel, Pacific Region, Resource Exploitation, Resource Exploration, Trade, United Kingdom, United States of America  /  Comments Off on MIL-OSI Australia: Medicines Safety Update, Volume 9, Number 2, June 2018

Source: Australian Therapeutic Goods Administration Medicines Safety Update is the medicines safety bulletin of the Therapeutic Goods Administration (TGA). In this issue Misadventures in oral methotrexate dosing Inadvertent overdose of oral methotrexate – usually from accidental daily administration of a weekly dose – can lead to serious and potentially fatal toxicity. Methotrexate is indicated for […]

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MIL-OSI Australia: Need for Seal tablets

By   /  June 28, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, Internet Communications Technology, law, Legal, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Need for Seal tablets

Source: Australian Therapeutic Goods Administration Need for Seal tablets pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled Need for Seal and found that: the tablets contain the undeclared substance sildenafil consumers are advised that sildenafil is a prescription-only medicine The supply […]

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MIL-OSI Australia: Gold Maka tablets

By   /  June 28, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Therapeutic Goods Administration, English, Health, Internet Communications Technology, law, Legal, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Gold Maka tablets

Source: Australian Therapeutic Goods Administration Gold Maka tablets pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled Gold Maka and found that: the tablets contain the undeclared substance sildenafil consumers are advised that sildenafil is a prescription-only medicine The supply of Gold […]

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