Blog
RSS FeedPosted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...
Posted by Michael Wonder on 15 May 2020
International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
15 May 2020 - Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of ...
Posted by Michael Wonder on 02 Oct 2019
How to ensure that novel analytic methods are fit for decision-making
2 October 2019 - The past decade has seen the increased generation and availability of new data sources such as ...
Posted by Michael Wonder on 11 Sep 2019
The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018
10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...
Posted by Michael Wonder on 23 Jan 2018
Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries
23 January 2018 - Although health technology assessment systems base their decision making process either on economic evaluations or comparative clinical ...
Posted by Michael Wonder on 23 Mar 2017
Use of big data to improve human and animal health
22 March 2017 - Task force to establish roadmap and recommendations for use of big data in assessment of medicines ...
Posted by Michael Wonder on 10 Mar 2017
EBE, EFPIA and IFPMA have today launched a position paper entitled “Considerations for physicians on switching decisions regarding biosimilars”
9 March 2017 - Switching describes a physician's decision to exchange one product that a patient receives for another. ...
Posted by Michael Wonder on 20 May 2016
Accessing key EMA information on human medicines
20 May 2016 - New guide to information about medicines evaluated by the EMA. ...
Posted by Michael Wonder on 28 Apr 2016
Involving general practitioners in regulatory decisions on medicines
28 April 2016 - EMA workshop with general practitioners and family doctors kicks off strengthened collaboration. ...
Posted by Michael Wonder on 01 Oct 2015
European Medicines Agency’s Management Board nominates Guido Rasi as Executive Director
1 October 2015 - The European Medicines Agency’s (EMA’s) Management Board has nominated Professor Guido Rasi as the Executive Director of ...
Posted by Michael Wonder on 29 Sep 2015
Management Board expected to nominate EMA Executive Director on 1 October 2015
29 September 2015 - The European Medicines Agency’s (EMA) Management Board will meet on Thursday 1 October for an extraordinary session. ...
Posted by Michael Wonder on 26 Sep 2015
EMA fast-tracks antidote to anticoagulant Pradaxa
25 September 2015 - The European Medicines Agency (EMA) has recommended granting a marketing authorisation, following accelerated assessment, for Praxbind (idarucizumab) ...
Posted by Michael Wonder on 26 Sep 2015
New medicine to treat heart failure recommended for approval
25 September 2015 - The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Entresto (sacubitril with valsartan) for ...
Posted by Michael Wonder on 26 Sep 2015
New treatment option for patients with rare blood cancer
25 September 2015 - The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Kyprolis (carfilzomib) to treat patients ...
Posted by Michael Wonder on 21 Sep 2015
CHMP Chair re-elected
21 September 2015 - The Committee for Medicinal Products for Human Use (CHMP) re-elected Dr Tomas Salmonson as its Chair at ...