clinical trials

End of financial year

Out They Go – FDA Clears the Store of Guidances

By Arthur Brandwood | 25 October, 2019
In a now traditional clearing of the store, FDA issued a raft of new guidances at the close of the financial year. Through September to October 10 a total of...
Red carpet

FDA Fashion Parade – Guidance Priorities for Fiscal 2020

By Arthur Brandwood | 25 October, 2019
Each new fiscal year, FDA sets out its priorities for guidance development and publication over the coming year. It’s always a fascinating insight into the current regulatory fashions, and just...
Implant

Custom Devices, Clinical Trials and the Hazards of Precedent

By Arthur Brandwood | 2 September, 2019
This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices. A surgeon inventor wanted to...

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Proposed delayed commencement of certain Medical Device Regulatory Changes

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Software as a Medical Device – Upcoming Changes to the Australian Regulations

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Keeping it Clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods

May 19, 2020

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