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EMA squeezes PIPs, wants firms to run more trials in children

This article was originally published in Scrip

Executive Summary

The European Medicines Agency has confirmed to Scrip’s sister journal, Scrip Regulatory Affairs, that its pediatrics committee (PDCO) is planning to revoke class waivers for pediatric investigation plans because the waivers are preventing the agency from requesting studies in children, especially in oncology. The plan was briefly mentioned in the minutes of the 5-7 September 2012 PDCO meeting, which were published online on 11 October 2012.

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