CANCER RESEARCH UK ATTACKS DRAFT EU MEDICINE GUIDANCE
September 1st, 2010
BY KEITH NUTHALL
CANCER Research UK has criticised European Commission draft guidance for non-investigational medicinal products (NIMPs) in clinical trial authorisation (CTA) submissions, claiming it could make some tests "unworkable".
The research group warns in formal consultation documents that the guidance "does not make appropriate allowances for trials in high morbidity diseases where patients will inherently be receiving a vast array of treatments (established and experimental), often over a considerable period of time..."
It warns ...
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