The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for pharmaceutical ...
The Therapeutic Goods Administration (TGA) is set to allow the sale of a limited range of self-test in vitro diagnostics (IVDs) in Australia. TGA proposed the regulatory change after GlaxoSmithKline ...
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