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Merck KGaA has withdrawn its EU marketing application for a lung cancer indication for its cancer drug Erbitux after regulatory authorities requested more clinical data.
Drug manufacturers should prepare to use the updated version of Module 1 of the electronic common technical document (eCTD) by September of next year, even though it will likely remain optional until 2015, FDA officials advise.
Fercy Personal Care Products, a Chinese OTC drugmaker, has been warned for a host of quality problems at its Jinhua, China, facility and for limiting investigators’ access to the unregistered plant.
Ben Venue subsidiary Bedford Laboratories is expanding its voluntary recall of chemotherapy drug leucovorin calcium due to crystalline particulates in a small number of vials.
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