1-10 of 51 results
Aged care reform: back on the agenda
In this Insight, we focus in on the key regulatory enforcement and provider governance reforms to be implemented under the Royal Commission Response Bill and the implications for approved providers. ...
Software-based medical devices: key regulatory requirements, IP considerations and data privacy implications
Software is increasingly being used as a medical device and in medical devices. It is crucial that businesses understand the regulations that can apply to software-based medical devices, the IP considerations if they wish to protect such devices and the privacy-related risks associated with the collection and use of data from such devices. This Insight explores each of these issues in turn. ...
Antibody patent protection in Australia
Many of the top selling drugs in Australia are antibodies, all part of a global market estimated to reach US$140 billion this year. Recently, the US FDA (Food and Drug Administration) approved the ...
Expansion in scope of transactions subject to FIRB approval rules
In this Insight, we look at the changes and comment on what they mean for transactions. The changes to the SOCI Act also have operational implications for many businesses – which we will separately publish on. ...
3D printing – new rules for personalised medical devices
Australia's new regulations governing personalised medical devices, including 3D-printed devices, will have significant effects. They narrow the definition of custom-made medical devices, which will continue to be given regulatory exemptions but be subject to more regulatory requirements. ...
Repurposing existing medicines – industry to have its say in reshaping Australia's regulatory future
The Therapeutics Goods Administration (the TGA) is consulting with the public and industry to potentially reform regulatory and reimbursement frameworks, to incentivise the repurposing of existing medicines. Off-label use (where a medicine is used for a disease or medical condition for which it does ...
A new rights-based approach: the Aged Care Royal Commission delivers its blueprint for radical reform
The Royal Commission into Aged Care Quality and Safety issued its Final Report, which recommends significant change through the creation of a new aged care system aimed at placing people at the centre of aged care. The recommendations are wide ranging. ...
Down-scheduling CBD and growing Australia's cannabis industry
The Therapeutics Goods Administration is proposing amendments to the Poisons Standard to permit pharmacists to sell low-dose cannabidiol (CBD) products without a prescription. Businesses intending to import, manufacture and supply cannabis products in the Australian market should monitor these developments closely. ...
Lorna Jane antivirus activewear claims don't workout
A recent set of infringement notices issued by the Therapeutic Goods Administration, including against clothing manufacturer Lorna Jane, highlights the importance of businesses carefully scrutinising all claims made about any health-related benefits of their products. We break down the elements of that case and its significance for advertising and marketing claims. ...
UK Supreme Court affirms jurisdiction to determine global FRAND terms
The UK Supreme Court's decision in Unwired Planet v Huawei confirms that disputes between organisations that own these patents, and equipment manufacturers that use the patents, can be brought and resolved on a worldwide basis in England. ...