EMA revising pediatric wavier forms

Many companies are hesitant to perform clinical studies on children due to the risks and ethical issues that can arise. This is why the European Medicines Agency (EMA) is looking into revising and reforming the product class waivers to allow companies to test new...

IOM report highlights benefits of pediatric drug studies

A report released Feb. 29th by the Institute of Medicine (IOM) provided a review of the benefits of current federal laws that offer incentives for or require drug and biologic developers to conduct pediatric studies.  The report also highlighted several areas where...