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Continuing Problems April 17, 2010

Posted by Michael Hamrell in Regulatory Thoughts.

As further evidence on continuing fall-out from the reported poor GCP compliance on their pivotal study for the new SSSI drug, ceftobiprole, Basilea and J&J have announced that the drug has been withdrawn from the market in Canada. After reported discussions with the Canadian authorities who expressed concerns over the potential integrity issues, the companies have voluntarily withdrawn the drug from the market. This represents a stunning reversal, where an approved drug is taken off the market after GCP problems were identified in audits conducted by FDA and EMA. This further underscores the importance of proper execution and compliance in the conduct of clinical trials. Even the EMA indicated that it appears the drug is safe and effective, but that they could not accept the data due to the integrity questions raised.



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