Blog
RSS FeedPosted by Michael Wonder on 21 Apr 2020
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. ...
Posted by Michael Wonder on 20 Apr 2020
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 ...
Posted by Michael Wonder on 06 Apr 2020
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 ...
Posted by Michael Wonder on 31 Mar 2020
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 ...
Posted by Michael Wonder on 20 Mar 2020
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 ...
Posted by Michael Wonder on 17 Mar 2020
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 ...
Posted by Michael Wonder on 17 Mar 2020
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 ...
Posted by Michael Wonder on 05 Mar 2020
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 ...
Posted by Michael Wonder on 01 Mar 2020
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 ...
Posted by Michael Wonder on 26 Feb 2020
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 ...
Posted by Michael Wonder on 19 Feb 2020
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 ...
Posted by Michael Wonder on 02 Feb 2020
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 ...
Posted by Michael Wonder on 23 Jan 2020
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 ...
Posted by Michael Wonder on 10 Dec 2019
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 ...
Posted by Michael Wonder on 04 Dec 2019
'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 ...