Posts tagged ‘Federal Institute for Drugs and Medical Devices’

07/12/2014

EU States Suspend Marketing of Drugs Tested at Lab in India – Businessweek

A European Union review of a contract lab in India hired by drugmakers to perform clinical trials pivotal to approval of certain generic medicines has led some member states to suspend marketing of those drugs.

The European Medicines Agency is reviewing findings GVK Biosciences, based in Hyderabad, India, didn’t comply with clinical practice standards, and the suspensions are a precaution until the review is finished, according to a statement yesterday from the agency. The EMA didn’t name the countries or the drugs being suspended, and its press representatives didn’t respond to a call and an e-mail after business hours.

The review is based on an inspection by the French medicine agency that raised concerns about the reliability of studies done at GVK Bio since 2008. The French agency inspected GVK Bio from May 19 to 23 and found falsification by at least 10 people between 2008 and 2013 of electrocardiograms in all of the nine trials they examined.

via EU States Suspend Marketing of Drugs Tested at Lab in India – Businessweek.

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