News
RAPS: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017)
11.05.2017
EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials.
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The ...
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The ...
RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance
23.03.2017
Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance
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FDA: Hypertension Indication: Drug Labeling for Cardiovascular
23.03.2017
This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling
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EMA: Promoting high-quality clinical research in children through strengthened international collaboration
10.02.2017
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its ninth annual workshop on 16 May 2017 in London, UK. The aim of the workshop, that will take
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1000th Procedure HMA Voluntary Harmonisation Procedure (VHP) for clinical trials
07.12.2016
The European Voluntary Harmonisation Procedure for clinical trials (VHP) was first established in March 2009. Now, the 1000th application for the evaluation of a clinical trial has been received
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EMA: Revising the guideline on first-in-human clinical trials
17.11.2016
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human
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RAPS: EMA Transparency: New Clinical Reports Go Live
17.11.2016
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
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FDA: Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease
29.09.2016
This guidance provides a qualified context of use (COU) for the biomarker plasma fibrinogen, in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high
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GMP: EMA - requirements for quality documentation concerning biological investigational medicinal products
08.09.2016
Already in 2012, the European Commission published a guideline on the quality documentation for IMP in clinical trials. Now on 23 June, the EMA issued a draft \"Guideline on the requirements for
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FDA: E17 General Principles for Planning and Design of Multi-Regional Clinical Trials This
08.09.2016
With the increasing globalisation of drug development, it has become important that data from multi-regional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and
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