FDAnews Drug Daily Bulletin

France Temporarily Halts AB Science’s Clinical Trials

May 19, 2017

France’s regulatory agency has temporarily suspended clinical trials for drugmaker AB Science, the company confirmed in a statement.

The company, which specializes in protein kinase inhibitors, received the suspension request following an inspection that discovered significant good clinical practice deviations. The Agence Nationale de la Sécurité des Médicaments called for the suspension of ongoing clinical trials until an external audit proved the company was compliant.

The inspection focused on clinical trials conducted between 2009 and 2015, before AB Science implemented a new quality system in mid-2015, according to the company. Since then, authorities have identified no further adverse events in site inspections. The company’s clinical trial procedures are now fully compliant, according to the statement, which added that an independent audit will be completed in the coming months.

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