Blog
RSS FeedPosted by Michael Wonder on 28 Jun 2020
Highlights from the June 22-25 CHMP meeting
26 June 2020 - EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its June 2020 meeting. ...
Posted by Michael Wonder on 23 Jun 2020
FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
23 June 2020 - The U.S. FDA today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence. ...
Posted by Michael Wonder on 15 Jun 2020
The pandemic claims new victims: prestigious medical journals
14 June 2020 - Two major study retractions in one month have left researchers wondering if the peer review process is ...
Posted by Michael Wonder on 04 Jun 2020
The Lancet, New England Journal retract COVID-19 studies, including one that raised safety concerns about malaria drugs
4 June 2020 - The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
Posted by Michael Wonder on 27 May 2020
EMA publishes agenda for 25-28 May 2020 CHMP meeting
27 May 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 May 2020
Federal scientists finally publish remdesivir data
23 May 2020 - A clinical trial led to the authorisation of the only drug shown to work in COVID-19 patients. ...
Posted by Michael Wonder on 06 May 2020
Scientific research on the coronavirus is being released in a torrent
6 May 2020 - Will that change how science is published? ...
Posted by Michael Wonder on 06 May 2020
Half yearly performance snapshot: July to December 2019
6 May 2020 - The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the ...
Posted by Michael Wonder on 05 May 2020
EMA publishes minutes of joint meeting with EUnetHTA - November 2019
5 May 2020 - This was the 18th meeting between the EMA and representatives from the EUnetHTA and attended by the ...
Posted by Michael Wonder on 29 Apr 2020
EMA publishes agenda for 28-30 April CHMP meeting
29 April 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Apr 2020
Improved Consumer Medicine Information template
20 April 2020 - The Therapeutic Goods Regulations 1990 have been amended to support improved Consumer Medicine Information. ...
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 15 Apr 2020
Product specific guidances for chloroquine phosphate and hydroxychloroquine sulphate
13 April 2020 - The FDA plays a critical role in protecting the United States from threats including emerging infectious ...
Posted by Michael Wonder on 08 Apr 2020
Submissions on whether the TGA should publish that a prescription medicine is under evaluation
8 April 2020 - Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the ...