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The French National Medicines Agency blocks vital data on hepatitis.
Friday 26 April 2013
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The French National Medicines Agency blocks vital data on hepatitis.
While an international conference on the Study of the Liver [1] in which important data is provided on clinical trials to evaluate new drugs against hepatitis is held in Amsterdam, we condemn the withholding of information the French National Medicines Agency (ANSM) oppose to the patient groups.
People in treatment failure risk of dying quickly should benefit from early access to developing drugs. There is a temporary use authorization procedure (ATU) for that. [2]
Applications for such permits were filed with the ANSM. On several occasions in recent weeks the agency has refused to disclose the number, the molecules involved and the health status of individuals for which they were requested.
We demand that these data be provided immediately.