When adult data were extrapolated to pediatric populations in drug development programs, more than 61% of those extrapolations were linked to new product labeling, according to study results.

The European Medicines Agency (EMA) released a reflection paper on Monday with the hope of helping drugmakers avoid unnecessary pediatric research by establishing a framework for extrapolating ...

A little more than a year after introducing the draft version, the US Food and Drug Administration (FDA) on Monday finalized guidance on how and when it may be appropriate to leverage existing ...

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ ...