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EMA to revoke PIP oncology waivers, says more cancer trials needed in children

This article was originally published in Scrip

Executive Summary

As a result of concerns that pharmaceutical companies are not conducting enough clinical trials in children, the European Medicines Agency's pediatrics committee (PDCO) is planning to revoke class waivers for paediatric investigation plans in some conditions on the grounds that the waivers are preventing the agency from requesting studies in children, especially in the field of oncology. The move would not affect drugs already on the market, unless they were submitted for review in additional indications.

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