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RSS FeedPosted by Michael Wonder on 23 Apr 2020
Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 27 April and on 1 May 2020
23 April 2020 - EMA has put measures in place to ensure that its activities related to the COVID-19 pandemic ...
Posted by Michael Wonder on 23 Apr 2020
COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine
23 April 2020 - Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated ...
Posted by Michael Wonder on 21 Apr 2020
Launch of enhanced monitoring system for availability of medicines used for treating COVID-19
21 April 2020 - EMA, together with the pharmaceutical industry and the EU Member States, has launched its enhanced fast-track ...
Posted by Michael Wonder on 20 Apr 2020
Update to guidance on regulatory expectations in the context of COVID-19 pandemic
20 April 2020 - The European Commission, EMA and the national competent authorities have agreed a series of measures to ...
Posted by Michael Wonder on 20 Apr 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #2
20 April 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 16 Apr 2020
EMA shares advice on validated computer systems used in clinical trials
16 April 2020 - The EMA has published a notice about validating and qualifying all types of computerised systems used ...
Posted by Michael Wonder on 14 Apr 2020
Regulators split on anti-malarials for COVID-19
11 April 2020 - US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and ...
Posted by Michael Wonder on 09 Apr 2020
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
9 April 2020 - As part of its health threat plan activated to fight COVID-19, the EMA has finalised and ...
Posted by Michael Wonder on 09 Apr 2020
Global regulators stress need for robust evidence on COVID-19 treatments
9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 ...
Posted by Michael Wonder on 07 Apr 2020
Global regulators discuss observational studies of real world data for COVID-19 medicines
7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...
Posted by Michael Wonder on 07 Apr 2020
Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from 9 to 13 April 2020
7 April 2020 - It is EMA's top priority to help save lives during the pandemic by expediting the development ...
Posted by Michael Wonder on 06 Apr 2020
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
6 April 2020 - The continued availability of medicines, in particular those used for patients with COVID-19, is of critical ...
Posted by Michael Wonder on 03 Apr 2020
EMA provides recommendations on compassionate use of remdesivir for COVID-19
3 April 2020 - During an extraordinary virtual meeting held on 2 April 2020, EMA’s CHMP gave recommendations on how ...
Posted 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 02 Apr 2020
EMA urges caution on malaria drugs' use for COVID-19 in absence of evidence
1 April 2020 - The European Union's drug regulator warned on Wednesday that two older malaria drugs being tested against ...