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Pharmacology

Accreditation of Phase I units in the UK

Published in Medical Letter on the CDC and FDA, June 3rd, 2007

There has been much debate following the adverse reactions to TGN1412 just over a year ago. Following the Duff report, draft guidelines on 'First-in-Man Clinical Trials' issued by the European Medicines Agency (EMEA) and the Medicines Healthcare Regulatory Authority (MHRA) are in public consultation.

We welcome the introduction of the new and improved guidelines as part of the continuous evolution of clinical research. Whilst many, if not all of the proposed new guidelines should be good clinical research practice in quality clinical trial units, the introduction of these guidelines can only help to further enhance the UK's standing as leaders in the conduct of Phase I...

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