Blog
RSS FeedPosted by Michael Wonder on 22 Sep 2018
The FDA announces Patient Engagement Advisory Committee meeting on utilising real world data from patient-driven platforms that connect and empower patients
21 September 2018 - On 15 November 2018, the FDA’s Patient Engagement Advisory Committee will hold its second public meeting ...
Posted by Michael Wonder on 14 Jun 2018
Building synergy between regulatory and HTA agencies beyond processes and procedures—can we effectively align the evidentiary requirements? A survey of stakeholder perceptions
13 June 2018 - The pathway for bringing a new medicine to the market is dependent on two sequential processes: achieving ...
Posted by Michael Wonder on 30 Jan 2018
The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendations.
30 January 2018 - The “Parallel regulatory-HTA scientific advice” procedure allows manufacturers to receive simultaneous feedback from both EU regulators and ...
Posted by Michael Wonder on 09 Dec 2017
Engaging with patients on health policy changes: an urgent issue
8 December 2017 - Back in the 1980s, when I was practicing as a faculty primary care physician at an academic ...
Posted by Michael Wonder on 15 Nov 2017
EMA to work with stakeholders to improve the product information for EU medicines
15 November 2017 - Stakeholder feedback sought on ongoing electronic initiatives ...
Posted by Michael Wonder on 11 Oct 2017
Statement by FDA Commissioner Scott Gottlieb on new steps by FDA to advance patient engagement in the agency’s regulatory work
11 October 2017 - The FDA is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory ...
Posted by Michael Wonder on 27 Jul 2017
FDA sets inaugural meeting of first-ever patient engagement advisory committee
25 July 2017 - Imagine checking your blood sugar levels several times a day with a glucose meter to keep your ...
Posted by Michael Wonder on 20 Jul 2017
EU watchdog concerned drug agency EMA may be too close to companies
19 July 2017 - The EMA, eager to accelerate access to promising new drugs, may be getting too cosy with ...
Posted by Michael Wonder on 19 Jun 2017
Emerging use of early health technology assessment in medical product development: a scoping review of the literature
20 June 2017 - Early health technology assessment is increasingly being used to support health economic evidence development during early stages ...
Posted by Michael Wonder on 08 May 2017
Involving patients in discussions on benefits and risks of medicines
8 May 2017 - EMA publishes report on CHMP pilot project. ...
Posted by Michael Wonder on 06 Dec 2016
Twelfth joint EMA/EUnetHTA dialogue meeting
5 December 2016 - The 12th joint meeting between the EMA and the European network for Health Technology Assessment (EUnetHTA) will ...
Posted by Michael Wonder on 05 Jul 2016
Top officials aim to reshape the FDA to prepare for 'avalanche' of cancer products
30 June 2016 - For 20 years, Richard Pazdur has run the office of the FDA charged with evaluating new cancer ...
Posted by Michael Wonder on 22 Jun 2016
EMA and FDA reinforce collaboration on patient engagement
22 June 2016 - New working group established to exchange best practices. ...
Posted by Michael Wonder on 21 Jun 2016
EMA publishes annual report on its interaction with patients, consumers, health care professionals and their organisations
21 June 2016 - The Agency has expanded activities that could involve patients and health care professionals. ...
Posted by Michael Wonder on 10 Jun 2016
EMA celebrates ten years of its patients and consumers working party
10 June 2016 - Join the live broadcast on Tuesday, 14 June from 14:00 to 17:00. ...