EMA To Improve Early Pediatric Advice Initiative
The European Medicines Agency is to fine tune its early interaction initiative to help companies shape their pediatric development plans alongside programs for adults.
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The research-based drug industry has not minced its words in describing the problems it has faced from the EU Paediatric Regulation over the past 10 years.
Agency provides early advice on pediatric development to only a handful of applications thus far.
EMA has gotten applications from sponsors for early advice on developing medicines for pediatric indications, under one-year pilot project.