Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2020
Strategic collaboration announced by NICE and Health Technology Wales
3 March 2020 - Collaboration outlines the strategic planning and delivery of independent and authoritative medical technology guidance. ...
Posted by Michael Wonder on 25 Feb 2020
TLV has decided on a policy for patient participation
21 February 2020 - TLV has taken another step in developing patient participation by developing a policy. ...
Posted by Michael Wonder on 19 Dec 2019
Regulatory agency expands cooperation with European counterparts
18 december 2019 - The Ministry of Food and Drug Safety said that it has signed multiple agreements with its ...
Posted by Michael Wonder on 02 Dec 2019
Engaging patients in medicines regulation: a tale of two agencies
2 December 2019 - The EMA and the US FDA have committed to engaging patients in their regulatory processes to promote ...
Posted by Michael Wonder on 26 Nov 2019
Teva, drug makers in talks with U.S. to end generics probes
26 November 2019 - Deferred prosecution agreements among resolutions discussed. ...
Posted by Michael Wonder on 25 Nov 2019
Acalabrutinib receives TGA approval for CLL and SLL cancers
25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...
Posted by Michael Wonder on 21 Nov 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia
21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...
Posted by Michael Wonder on 13 Nov 2019
Regulators’ advice can make a difference for faster patient access to highly innovative therapies
12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play ...
Posted by Michael Wonder on 13 Nov 2019
FDA’s Project Orbis may expand to Singapore and Switzerland
12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...
Posted by Michael Wonder on 13 Nov 2019
ICER finalises method adaptations for assessing potential cures and other high-impact single or short-term therapies
12 November 2019 - Collaborative project with NICE and CADTH leads to important adaptations for ICER’s methods including creation of optimistic ...
Posted by Michael Wonder on 10 Nov 2019
Patient perspective is vital to FDA's work
7 November 2019 - As an oncologist, I was eager to come work at the U.S. FDA, where I knew ...
Posted by Michael Wonder on 05 Nov 2019
NICE International returns to deal with growing overseas enquiries
5 November 2019 - Division will offer an advisory service to international organisations, ministries and government agencies. ...
Posted by Michael Wonder on 26 Oct 2019
Dialogue with Chinese authorities on medicine regulation
25 October 2019 - The Deputy Commissioner of the Chinese National Medical Product Administration, Dr Chen Shifei, visited EMA on ...
Posted by Michael Wonder on 23 Sep 2019
Statement on FDA efforts to encourage patient engagement in medical device clinical investigations
23 September 2019 - At the U.S. FDA we are committed to keeping patients, their families and caregivers at the center ...
Posted by Michael Wonder on 17 Sep 2019
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence. ...