Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2020
International regulators discuss available knowledge supporting COVID-19 medicine development
3 April 2020 - On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by ...
Posted by Michael Wonder on 31 Mar 2020
Advancing regulatory science in the EU – new strategy adopted
31 March 2020 - EMA has published its Regulatory Science Strategy to 2025 today. ...
Posted by Michael Wonder on 24 Mar 2020
Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 23 Mar 2020
FDA and EMA collaborate to facilitate SARS-CoV-2 vaccine development
23 March 2020 - Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed ...
Posted by Michael Wonder on 19 Mar 2020
Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
19 March 2020 - EMA’s Human Medicines Committee has published a statement urging the EU research community to prioritise large randomised ...
Posted by Michael Wonder on 18 Mar 2020
First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
18 March 2020 - Today, the first global regulatory workshop on COVID-19, was convened under the umbrella of the International Coalition ...
Posted by Michael Wonder on 14 Mar 2020
COVID-19: developers of medicines or vaccines to benefit from free scientific advice
13 March 2020 - EMA provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat ...
Posted by Michael Wonder on 05 Feb 2020
EMA to support development of vaccines and treatments for novel coronavirus
4 February 2020 - To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA ...
Posted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 24 May 2019
EMA facilitates early engagement with medicine developers to combat antimicrobial resistance
24 May 2019 - As of today, EMA is opening up the early dialogue available through its Innovation Task Force ...
Posted by Michael Wonder on 09 Apr 2019
Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances
8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...
Posted by Michael Wonder on 28 Feb 2019
“Repurposing” off-patent drugs offers big hopes of new treatments
28 February 2019 - Towards the end of 2014 a 66-year-old British man named Alistair had a seizure. A scan ...
Posted by Michael Wonder on 14 Jan 2019
Revised guideline aims to strengthen global approach to development of new antibacterial medicines
14 January 2019 - EMA has published a PDF revision of its guideline on the evaluation of human medicines ...
Posted by Michael Wonder on 30 Nov 2018
Data from patient registries to replace clinical trials in previously untreated haemophilia patients
30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...
Posted by Michael Wonder on 29 Nov 2018
The evolution of adaptiveness: balancing speed and evidence
29 November 2018 - 'Adaptive' approaches to bringing drugs to market have been widely discussed in recent years. ...