This article was originally published in RAJ Devices
Argentina sets out new requirements for registering devices
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Biocon-Mylan press ahead with plans to broaden patient access in the US to biosimilar pegfilgrastim and are enthused with the initial uptake for their trastuzumab biosimilar ahead of more upcoming competition. A mid-2020 US launch for partnered insulin glargine is also on course.
Consultant John McKay encourages device makers to ask questions of the US FDA’s inspection team during a facility audit. Check out his advice here.