EMA revision of class waivers expected to stimulate development of pediatric medicines
The European Medicines Agency’s Pediatric Committee (PDCO) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan (PIP).
These are the most extensive revisions to date, and aim to better balance the need to support development of medicines in children with the goal of avoiding exposing children to unnecessary studies. The revisions will, hopefully, encourage companies to develop more new medicines for use in children, the EMA stated.
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