Blog
RSS FeedPosted 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 29 Jun 2016
Statement from FDA Commissioner announcing the acting director of the FDA Oncology Center of Excellence
29 June 2016 - The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative ...
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 15 Jun 2016
$4.5 million behind new pill to tackle Australia’s number one killer
15 June 2016 - A new pill designed to reduce the devastating toll of heart disease and stroke in Australia and ...
Posted by Michael Wonder on 10 Jun 2016
Regulator says too many drug makers chasing same cancer strategy
10 June 2016 - A new type of cancer drug that takes the brakes off the body's immune system has given ...
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. ...
Posted by Michael Wonder on 22 Apr 2016
Integrating patients’ views in clinical studies of anti-cancer medicines
22 April 2016 - The EMA has published new guidance on the use of patient-reported outcome (PRO) measures in oncology ...
Posted by Michael Wonder on 20 Apr 2016
FDA's breakthrough therapy designation and expedited review programs: Part I
20 April 2016 - A CDER Conversation with Richard Moscicki, M.D., Deputy Director for Science Operations, Center for Drug Evaluation and ...
Posted by Michael Wonder on 14 Apr 2016
Promoting high-quality clinical research to develop more and better medicines for children
14 April 2016 - EMA workshop scheduled for 2 June 2016 opens for registration. ...
Posted by Michael Wonder on 14 Apr 2016
Co-operation between regulators and HTA bodies creates synergies
14 April 2016 - The EMA and the European network for Health Technology Assessment (EUnetHTA) published today a report on their ...
Posted by Michael Wonder on 13 Apr 2016
Seamless oncology drug development
13 April 2016 - For more than half a century, the clinical development of anti-cancer drugs has followed a predictable and ...