Blog
RSS FeedPosted by Michael Wonder on 18 Aug 2020
EMA publishes agenda for 17-20 August CHMP meeting
18 August 2020 - The EMA has published a draft agenda for this week's CHMP meeting (written procedure). ...
Posted by Michael Wonder on 18 Aug 2020
FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short
18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that ...
Posted by Michael Wonder on 17 Aug 2020
Acute myeloid leukaemia: developing drugs and biological products for treatment
17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological ...
Posted by Michael Wonder on 21 Jul 2020
TGA publishes AusPAR for Vemlidy
21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...
Posted 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. ...