Why countries can’t meet the demand for gear against COVID-19

19 April 2020 - A host of efforts are under way to unblock bottlenecks. ...

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Crisis or not, Alberta must not do an end-run around Health Canada

20 April 2020 - On April 12, in response to a perceived delay in Health Canada’s approval of a Canadian-made ...

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COVID-19 update: daily roundup 6 April 2020

6 April 2020 - The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort ...

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Expedited COVID-19 medical device application process

31 March 2020 - The Therapeutic Goods Administration is currently undertaking an expedited assessment process for all medical devices associated with ...

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Generating comparative evidence on new drugs and devices before approval

21 March 2020 - Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment ...

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Mass shipment of testing kits arrives as government pleads for supplies

17 March 2020 - The first shipment among 100,000 new coronavirus testing kits were due to arrive in Australia on ...

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FDA provides more regulatory relief during outbreak, continues to help expedite availability of diagnostics

16 March 2020 - Today, as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated ...

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Allergan receives FDA approval for Durysta (bimatoprost implant) the first and only intracameral biodegradable sustained-release implant to lower intra-ocular pressure in open-angle glaucoma or ocular hypertension patients

5 March 2020 - Durysta lowered intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension by approximately 30% from baseline ...

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Health insurers call for prostheses tender

2 March 2020 - Health insurers are calling for the Morrison government to step away from pricing replacement hips, knees ...

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FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications

26 February 2020 - Today, the U.S. FDA is announcing the voluntary electronic Submission Template And Resource (eSTAR) Pilot Program as ...

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Medical device application processing times

19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review ...

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Medical device price savings for millions of Australians from today

1 February 2020 - The price of thousands of medical technologies treating heart and lung disease, diabetes, bone cancer, eye ...

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Hunt denies helping Liberal donor push for regulator's review

23 January 2020 - Health Minister Greg Hunt has denied accusations he interfered in a regulator's decision on whether to ...

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FDA approves etectRx ‘digital pill’ as rivals struggle

10 December 2019 - The FDA has approved an ingestible event marker from the privately-held digital health company etectRx, as ...

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'Cannot be trusted ... causing harm': top medical journal takes on big pharma

4 December 2019 - A leading medical journal is launching a global campaign to separate medicine from big pharma, linking ...

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