Celixir, a British regenerative medicine company formerly known as Cell Therapy Ltd, was handed a first-of-its-kind infringement notice by the UK’s drug regulator, the MHRA, after it failed to comply with a multitude of good clinical practice (GCP) regulations.
Key Takeaways
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An MHRA investigation of a clinical trial being run by Celixir revealed nine major and three serious findings in relation to good clinical practice principles.
The notice, published on 17 July, dated back to a 2020 GCP inspection of a trial sponsored by Celixir. Although...
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