Blog
RSS FeedPosted by Michael Wonder on 14 Mar 2019
An EU wide approach to HTA: an irrelevant development or an opportunity not to be missed?
14 March 2019 - An EU-wide cooperation on HTA has been proposed recently by the European Commission, focusing on relative effectiveness ...
Posted by Michael Wonder on 06 Feb 2019
NICE collaborates with the Canadian Agency for Drugs and Technology in Health to offer parallel scientific advice
6 February 2019 - NICE and the Canadian Agency for Drugs and Technology in Health have launched a new collaboration to ...
Posted by Michael Wonder on 06 Feb 2019
New opportunity: parallel scientific advice from CADTH and NICE
6 February 2019 - CADTH is pleased to announce a new collaboration with England’s NICE (National Institute for Health and ...
Posted by Michael Wonder on 23 Jan 2019
ICER launches international collaborative to develop new methods to guide value-based pricing of potential cures
23 January 2019 - NICE in the UK and CADTH in Canada among international agencies participating; public input on key methodological ...
Posted by Michael Wonder on 18 Dec 2018
Our door is open: FDA puts patients first
18 December 2018 - We believe patients are experts when it comes to their health conditions. ...
Posted by Michael Wonder on 30 Nov 2018
FDA announces pilot program with WHO to expedite review of HIV drug applications
30 November 2018 - The U.S. FDA today announced a plan to work with the WHO to pilot a process to ...
Posted by Michael Wonder on 02 Nov 2018
Comparable overseas reports pathway - first registration decision
2 November 2018 - Cabozantinib (Cabometyx) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 01 Nov 2018
Update on the Australia-Canada Mutual Recognition Agreement
1 November 2018 - Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement (as of November 1, ...
Posted by Michael Wonder on 17 Oct 2018
FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety
16 October 2018 - As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. FDA ...
Posted by Michael Wonder on 26 Sep 2018
Early dialogue in Europe: perspectives on value, challenges, and continuing evolution
24 September 2018 - This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for ...
Posted by Michael Wonder on 20 Sep 2018
Portugal to also benefit from EU-US mutual recognition agreement for inspections
20 September 2018 - Agreement now operational between 15 EU Member States and FDA. ...
Posted by Michael Wonder on 18 Sep 2018
Australia unveils strategy for engaging with foreign regulators
17 September 2018 - Australia’s TGA revealed a three-part plan on Monday to operationalise its strategy on engaging international regulators ...
Posted by Michael Wonder on 18 Sep 2018
TGA international engagement strategy: operations plan 2018-19
17 September 2018 - To support Australian regulatory decisions the TGA considers international reports and evaluations, monitor early warnings and ...
Posted by Michael Wonder on 17 Sep 2018
Dutch, Swiss regulators forge agreement on data exchange
14 September 2018 - The heads of the Netherland’s Medicines Evaluation Board and Swissmedic have signed a memorandum of understanding ...
Posted by Michael Wonder on 05 Sep 2018
New program with payers aims to accelerate patient access to medical devices
5 September 2018 - Advancing the public health means helping to make sure patients have access to safe, effective medical products. ...