241-250 of 324 results
Assessment of biosimilars - Is Australia leading, following or going its own way?
The ongoing lack of certainty about what is required to obtain biosimilar registration in Australia extends to three key issues - Comparability is the new product sufficiently similar to permit it to rely on the reference products safety and efficacy data Extrapolation for which of the indications ...
It's that time of year again - is your product safety house in order?
Product safety has been high on the ACCCs agenda in 2018 and with the holiday retail frenzy about to begin it should also be high on the agenda of all retailers and suppliers Following on from International Product Safety Week last week it is a good time for businesses to review their processes and ...
An overhaul of regulation of software as a medical device - what's on the horizon?
Proposed new regulatory rules for software as a medical device will if enacted have serious implications for suppliers to the Australian market who will likely have to meet more stringent requirements that could conflict with those in the US and Europe Special Counsel Ric Morgan and Senior Associate ...
'Fairness in Franchising' report: What you need to know
The Parliamentary Joint Committee on Corporations and Financial Services has completed its inquiry into the operation and effectiveness of the Franchising Code of Conduct the Franchising Code The Committees report recommends 71 wide-ranging recommendations to address perceived power imbalances and ...
Faster TGA disclosure - what it means for pharmaceutical patent litigation
The TGA has consulted on whether it should disclose earlier that a prescription medicine is under evaluation and what types of prescription medicines should be published. ...
Sugar is a health hazard
The Federal Court has found that the packaging of the Little Kids Shredz childrens food range produced by food giant Heinz was misleading to consumers because it suggested the high sugar products were nutritious and healthy ...
Australia releases model for implementing the Nagoya Protocol
The Federal Government has released a model for the implementation of the Nagoya Protocol that will have major implications for those who use genetic resources and associated traditional knowledge for biodiscovery Partner Sarah Matheson and Lawyer Julieane Bull provide an overview of changes ...
The ramifications of a Facebook rant
The Full Court of the Federal Court recently handed down its decisions on an appeal that highlights the dangers of making unsubstantiated social media comments Partner Miriam Stiel and Lawyer Tracy Lu report on a long-running dispute where the court found personal Facebook posts constituted ...
Food Law Bulletin
we look at the ACCCs current enforcement activities on credence claims in food labelling the development of a national information standard for the contentious area of free-range eggs in light of the industrys failure to selfregulate a Federal Court decision that provides some welcome clarification ...
The ending point for 'starting point'
The Full Federal Court has published its much-anticipated judgment in the AstraZeneca v Apotex appeal A bench of five judges heard the appeal in contrast to the usual three judges in order to be able to clarify or overrule if appropriate an earlier Full Court decision relating to the correct test ...