Search Results for clinical trial transparency

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Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds By Zachary Brennan - Published 05 December 2017

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ.

Categories: News, US, FDA, Clinical, Research and development

Tags: clinical trial transparency, Johnson & Johnson, Sanofi, Valeant, Allergan

Researchers Call on FDA to Follow EMA's Lead in Publishing Study Reports By Michael Mezher - Published 22 February 2017

Two researchers are calling on the US Food and Drug Administration (FDA) to follow the European Medicines Agency's (EMA) lead in proactively publishing clinical study reports.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: Clinical Trial Transparency

EMA Revises Clinical Data Publication Guidance, Updates on Program By Michael Mezher - Published 09 December 2016

The European Medicines Agency (EMA) on Friday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect in October.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: Clinical trial transparency, Clinical study reports

EMA Transparency: New Clinical Reports Go Live By Michael Mezher - Published 20 October 2016

The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a new online database.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: Clinical trial transparency

EMA Contests Two Judicial Decisions Over Clinical Trial Transparency Efforts By Zachary Brennan - Published 29 September 2016

The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: DMD drugs, PTC Therapeutics, clinical trial transparency, President of the General Court of the EU

Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance? By Zachary Brennan - Published 16 September 2016

The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via ClinicalTrials.gov, though it remains to be seen if the $10,000 per day penalties from the US Food and Drug Administration (FDA) will be strictly enforced.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Drugs

Tags: clinical trials, final NIH rule, clinical trial transparency, FDA penalties, clinicaltrials.gov

UK Prime Minister Calls for Greater Clinical Trial Transparency in Emergencies By Michael Mezher - Published 08 June 2015

In response to the shortfalls in the international response to the Ebola outbreak, UK Prime Minister David Cameron is proposing a plan to boost research and transparency in the hopes of better confronting future public health crises.

Categories: News, Europe, Biologics and biotechnology, Clinical, Drugs, Government affairs, Research and development

Tags: Ebola, G7 summit, Clinical trial transparency

Company Challenges UK Clinical Trial Transparency Rules By Michael Mezher - Published 18 May 2015

An initiative to increase clinical trial transparency in the UK is being challenged in court after a successful petition by a company that conducts clinical trials for the pharmaceutical companies, The Guardian reports.

Categories: News, Europe, Clinical

Tags: HRA, Health Research Authority, Clinical Trial Transparency, Clinical Data Transparency

Study Claims German Dossier Requirements Could Improve Open Access to Trial Data By Michael Mezher - Published 03 March 2015

A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports.

Categories: News, Europe, EMA, Clinical, Ethics, Government affairs, Regulatory strategy, Reimbursement, Submission and registration

Tags: IQWiG, Health Technology Assessment, AMNOG, Clinical Trial Transparency

In Landmark Vote, EU Passes New Clinical Trial Regulation, Including Data Transparency Measures By Alexander Gaffney, RAC - Published 02 April 2014

Tags: Clinical Trial Transparency, 2001/20/EC, European Parliament, CTD, Clinical Trials Directive, Transparency, Latest News, clinical trials, EU