TGA expedites COVID-19 approvals, while keeping up business as usual for other devices
The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the...
Expedite! Emergency device regulatory approvals in a pandemic
These are difficult times – and we need fast, really fast, regulatory reviews. So how does this work – how have regulators adapted to the COVID-19 pandemic? What new and...
Six uncomfortable regulatory truths in a pandemic
These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having...
Getting Shorty – Meeting your obligations for Reporting Medicines Shortages in Australia
Ensuring adequate medicine supply to satisfy market demand is a complex business. Many products can have multinational supply chains using different suppliers of raw materials and ingredients and utilise manufacturers...