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Australian Prescription Medicine Pathways – Project Orbis

By Luis Jimenez | 1 September, 2020
Project Orbis is an initiative of the US FDA Oncology Centre of Excellence (OCE). The intent of Project Orbis is to provide a framework for concurrent submission and review of...
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Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

By Reena Patel | 19 June, 2020
As described in the Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform article the transition period for Australian Medicines Packaging Reform concludes on 31 August 2020. As a...
Medicine packaging

Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform

By Reena Patel | 18 May, 2020
2020 was flagged to be a big year for TGA Sponsors of Medicines with two long-standing milestones on the horizon. Whilst there is no doubt this won’t be a year...

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Recent Posts

New Guidance on FDA ISO 10993-1

Sep 14, 2020

Australian Prescription Medicine Pathways – Project Orbis

Sep 1, 2020

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Aug 31, 2020

Chemical Characterisation – no simple matter

Aug 28, 2020

Multiple Function Devices

Aug 26, 2020

Impact of COVID-19 on Medical Device Sales and Reimbursement in Australia

Aug 10, 2020

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