The TGA have just approved the first medicine via the provisional approval pathway (17th July, 2019) for Pembrolizumab (KEYTRUDA). First provisional approval | Therapeutic Goods Administration (TGA)… This is a major milestone and will, no doubt, encourage other companies to consider filing this way in Australia. What is Australia’s ‘Provisional Approval Pathway’? As part of […]
So, don’t limit your company to the talent pool within easy driving distance of the office. Instead, get an edge over your competitors. There is a world of expertise out there to be had, just connect.
Without a coherent commercialization strategy and an integrated development plan, you’ll waste time and money. Pharmaceutical Development Planning It’s often said that failing to plan is planning to fail. I disagree. You can go on and on for years without a plan, burning money, wasting time, losing good staff and not actually “failing”. Obviously, this […]
Medsafe NZ has now released a consultation document on the proposed Therapeutic Products Regulatory Scheme.