The new US financial year as always heralds increases in regulatory fees – around 4% across the board. We take a look at the current costs of US approvals.
With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently.
New draft FDA guidance attempts a formal framework for the art of dealing with uncertainty, speaks to perspectives of all players – including the patient.
In a proposed rule announced 13 September, US FDA plans to do away with paper submissions. The agency isn’t quite going fully digital yet – you still have to mail…
During August, the Therapeutic Goods Administration (TGA) published their 2017 overview of post market monitoring in Australia.