Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 15 Sep 2018
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...
Posted by Michael Wonder on 06 Aug 2018
MHRA clarifies post-Brexit clinical trials rules
8 August 2018 - The MHRA has clarified how the UK’s clinical trials rules will function in partnership with the ...
Posted by Michael Wonder on 01 Feb 2018
EU proposes joint studies to speed acceptance of new medicine
31 January 2018 - The European Commission proposed on Wednesday joint clinical assessments to determine whether approved new drugs and ...
Posted by Michael Wonder on 13 Nov 2017
Nearly half of recent EU approvals based on a single pivotal study
10 November 2017 - A recent study found that 45% of marketing authorizations granted in the EU from 2012 to ...
Posted by Michael Wonder on 29 Jul 2017
Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study
26 July 2017 - Goldacre et al. set out to identify the policies of major pharmaceutical companies on transparency of trials, ...
Posted by Michael Wonder on 25 Jul 2017
Revised guideline on first-in-human clinical trials
25 July 2017 - Guidance outlines strategies to identify and mitigate risks for trial participants. ...
Posted by Michael Wonder on 12 Jun 2017
Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...
Posted by Michael Wonder on 06 Jun 2017
Workshop: addressing unmet needs of children with pulmonary arterial hypertension
6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...
Posted by Michael Wonder on 23 Mar 2017
Call for experts in anonymisation of clinical data
23 March 2017 - EMA to set up technical group in the context of the publication of clinical data ...
Posted by Michael Wonder on 14 Mar 2017
Release of documents on two medicines temporarily halted
14 March 2017 - EMA’s appeals against interim measures are dismissed by Court of Justice ...
Posted by Michael Wonder on 09 Mar 2017
UK children with cancer could miss out on drug trials after Brexit, doctors warn
9 March 2017 - Fears youngsters could be denied access to Europe-wide tests of new medicines when Britain leaves EU amid ...
Posted by Michael Wonder on 27 Feb 2017
GSK ‘real world’ study offers new model for drug trials
27 February 2017 - Pharma groups look to evidence in normal medical settings to prove value for money. ...
Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades. ...
Posted by Michael Wonder on 01 Feb 2017
Clinical data for two more medicines now available online
1 February 2017 - First publication of clinical data corresponding to a withdrawn application. ...