Blog
RSS FeedPosted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
Posted by Michael Wonder on 20 Oct 2017
New action plan to foster development of advanced therapies
20 October 2017 - Actions address specific challenges identified by stakeholders. ...
Posted by Michael Wonder on 01 Aug 2017
EMA encourages tailored development of medicines for older people
1 August 2017 - EMA invites comments on reflection paper by 31 January 2018. ...
Posted by Michael Wonder on 29 Jul 2017
Concept paper on development and lifecycle of personalised medicines and companion diagnostic
28 July 2017 - Public consultation to end on 31 October 2017. ...
Posted by Michael Wonder on 25 Jul 2017
Revised guideline on first-in-human clinical trials
25 July 2017 - Guidance outlines strategies to identify and mitigate risks for trial participants. ...
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 06 Jul 2017
Brexit must not disrupt drug R&D, say pharma chiefs
6 July 2017 - Industry lobbying began shortly after British referendum last June. ...
Posted by Michael Wonder on 03 Jul 2017
EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease
3 July 2017 - Approach aims to facilitate development of medicines for rare paediatric diseases in general. ...
Posted by Michael Wonder on 12 Jun 2017
Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...
Posted by Michael Wonder on 06 Jun 2017
Workshop: addressing unmet needs of children with pulmonary arterial hypertension
6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...
Posted by Michael Wonder on 07 Mar 2017
Personalised medicines – focus on patients and healthcare professionals
7 March 2017 - EMA workshop will discuss role of patients, consumers and health care professionals. ...
Posted by Michael Wonder on 27 Feb 2017
GSK ‘real world’ study offers new model for drug trials
27 February 2017 - Pharma groups look to evidence in normal medical settings to prove value for money. ...
Posted by Michael Wonder on 09 Feb 2017
Promoting high-quality clinical research in children through strengthened international collaboration
9 February 2017 - Enpr-EMA workshop on 16 May 2017 opens for registration. ...
Posted by Michael Wonder on 06 Feb 2017
Advanced therapy medicines: towards increased development and patient access
6 February 2017 - Follow-up activities addressing stakeholder needs. ...
Posted by Michael Wonder on 02 Feb 2017
Outcomes of early health technology assessment dialogues in medicinal product development
2 February 2017 - The development of medicinal products has been shifting towards a value-driven model. ...