Warning: This medical device literature review may contain traces of LBS
With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation…
Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market
The key to a successful plan is finding the right resources to help us make informed decisions that suit our…
Medicine labels: TGO 91 and TGO 92. What’s the impact?
The creation of separate orders for prescription and non-prescription medicines was implemented to reflect how the products are used and ensure adequate information is available for the safe use of…
Are you eCTD ready?
While the eCTD format is not currently mandatory in Australia, it is only a matter of time before the TGA joins other global regulators in mandating…
Stressed? Well your products should be!
Stress-testing is an important validation consideration and should be conducted very early in the development or implementation of new test methods rather than leaving it until regulatory authorities raise questions…
Keys to off-label communications
The TGA and the Medicines Australia Code of Conduct are very clear on the appropriateness and dissemination of off-label information to…
Is our product a medicine, a device, a cosmetic, an OTG or a food… and what could it be?
An increasing number of traditionally pharma/device companies are crossing boundaries to offer their patients a product portfolio spanning several product categories….
Using an overseas reference product in your bioequivalence studies
In order to consider whether this process is possible, the TGA have a list of exclusion criteria regarding the use this…
Release for supply – What every sponsor should know
Every batch of medicine sold or supplied in Australia is required to have undergone a “release for supply”…