Blog
RSS FeedPosted by Michael Wonder on 08 Sep 2016
Fighting antimicrobial resistance globally
7 September 2016 - EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new anti-bacterial agents. ...
Posted by Michael Wonder on 19 Aug 2016
“Adaptive pathways” to drug authorisation: adapting to industry?
16 August 2016 - The evidence for benefits of adaptive pathways to patients and public health is lacking or contradictory, ...
Posted by Michael Wonder on 16 Aug 2016
Addressing challenges of innovative cancer immunotherapy medicines
16 August 2016 - EMA workshop to discuss treatments based on genetically modified T-cells. ...
Posted by Michael Wonder on 04 Aug 2016
Adaptive pathways: key learnings and next steps
3 August 2016 - EMA publishes report on pilot project and will organise workshop in December to further explore concept ...
Posted by Michael Wonder on 03 Aug 2016
New layout for EMA scientific guidelines
2 August 2016 - Improved presentation to help website users. ...
Posted by Michael Wonder on 01 Aug 2016
Development of medicines to treat tuberculosis
1 August 2016 - Comments on draft guidance invited until 31 January 2017. ...
Posted by Michael Wonder on 31 Jul 2016
Modelling and simulation in the development and regulatory review of medicines
29 July 2016 - Comments on new guidance invited until 31 January 2017. ...
Posted by Michael Wonder on 21 Jul 2016
Proposals to revise guidance on first-in-human clinical trials
21 July 2016 - Comments invited on a concept paper on changes intended to support best practices. ...
Posted by Michael Wonder on 30 Jun 2016
Strengthening interaction with academia
30 June 2016 - EMA consults academia in preparation of a framework of collaboration. ...
Posted by Michael Wonder on 27 Jun 2016
The role of single-arm trials in the authorisation of new cancer medicines (update)
27 June 2016 - Joint EMA/ESMO workshop to be broadcast live on 30 June 2016. ...
Posted by Michael Wonder on 23 Jun 2016
EMA workshop on single-arm trials in oncology
23 June 2016 - The EMA has published the agenda for the upcoming workshop. ...
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 03 Jun 2016
Regulation of advanced therapy medicines
3 June 2016 - Report details concrete proposals to encourage development and authorisation of advanced therapy medicinal products (ATMPs) in the ...
Posted by Michael Wonder on 01 Jun 2016
First statistics on PRIME are released
1 June 2016 - Four medicines in development are accepted under the scheme. ...