Call for all sponsors to publish clinical trial results in EU database

3 July 2019 - The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have co-signed a ...

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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.  ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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Revised guideline on first-in-human clinical trials

25 July 2017 - Guidance outlines strategies to identify and mitigate risks for trial participants. ...

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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. ...

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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 ...

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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 ...

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Release of documents on two medicines temporarily halted

14 March 2017 - EMA’s appeals against interim measures are dismissed by Court of Justice ...

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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 ...

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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. ...

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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.  ...

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