guidance

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TGA deploys Post Market Review Compliance Dashboard

Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to...
Time Lapse

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their Conformity Assessment Documents in response...
FDA

New Guidance on FDA ISO 10993-1

On 4 September 2020 FDA re-issued their guidance on the use of ISO 10993-1 and Biocompatibility. I don’t think anyone saw this coming. It’s a big surprise! But the good...
End of financial year

Out They Go – FDA Clears the Store of Guidances

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

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...

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