Tag Archives: Therapeutic Goods Administration

Key reforms in TGA agenda for 2019-20

The Therapeutic Goods Administration has released its annual business plan update, revealing a focus on major regulatory reform and a continued international perspective for 2019-20. The updated plan sets out the organisation’s product regulation, regulatory reform, international engagement and regulatory compliance agenda along with an overview of key activities and …

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Kisqali a cancer treatment option for younger women

Aromatase inhibitor (AI), Kisqali, a CDK4/6 inhibitor has received a specific indication from the Therapeutic Goods Administration (TGA) for use in pre-/peri-menopausal Australian women with advanced metastatic HR+/HER2-breast cancer. This is said to be supported by significant overall survival data from the study, MONALEESA-7. MONALEESA-7 has reportedly demonstrated Kisqali significantly …

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Pure caffeine sales ban

Following a report into the safety of caffeine powders and highly concentrated caffeine products, the Morrison government has banned the sale of pure and highly concentrated caffeine food products for personal consumption. The ban comes as a result of a report commissioned by Minister for Aged Care and Senior Australians …

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E-cigarettes linked to severe lung illness

A statement on e-cigarettes has been issued by Australia’s Chief Medical Officer, following multiple US deaths linked to vaping, and warnings by the US Centres for Disease Control regarding the use of e-cigarettes. The statement, issued jointly by the Chief Medical Officer and State and Territory Chief Health Officers, refers …

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Vaporisers pass the TGA smoke screen

The Therapeutic Goods Administration (TGA) has this week approved the registration of a range of medically approved vaporisers in Australia. The approval of the Storz & Bickel GmbH & Co. KG medical standard vaporisers has been welcomed by Spectrum Therapeutics Australia (Spectrum), the medical division of Canopy Growth Corporation Australia …

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New e-learning modules for pharmacists

The Pharmaceutical Society of Australia (PSA) and the Pharmacy Guild of Australia (Guild), in partnership with the Therapeutic Goods Administration (TGA) have developed two new e-learning modules for pharmacists. The e-learning modules are said to be designed to help pharmacists increase their knowledge of the regulatory requirements applied to complementary …

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TGA up-schedules modified-release paracetamol

Pharmacists may need to step in and evaluate the current medicinal treatments of Australians who suffer from osteoarthritis pain. This followes a decision by the Therapeutic Goods Administration (TGA) to up-schedule modified-release paracetamol products such as Panadol Osteo from June 1, 2020. The decision by the Therapeutic Goods Administration (TGA) …

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Tecentriq combo gets TGA approval for lung cancer

Roche has welcomed the Therapeutic Goods Administration’s approval of Tecentriq in combination with Avastin and chemotherapy as an initial treatment option for adults with metastatic non-squamous non-small cell lung cancer (NSCLC). Adding Tecentriq (atezolizumab) to a combination of Avastin(bevacizumab) and chemotherapy reduces the risk of metastatic non-small cell lung cancerin patients. Approval was based …

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