UK Retiring eSUSAR Portal For Reporting Clinical Trial Safety Issues
Study sponsors still using the MHRA’s eSUSAR website for trial safety reporting are being urged to update their processes by 30 September.
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The UK Medicines and Healthcare products Regulatory Agency will as of 1 September 2010 accept only electronic submissions of reports of suspected unexpected serious adverse reactions (SUSARs) that occur during pharmaceutical clinical trials1.
A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.