Some form of data extrapolation – either full or partial – was used in making more than 63% of pediatric labeling changes in the United States between 2015 and 2021, according to a new analysis. The ...

Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug development but suggest ...

The Food and Drug Administration issued a final guidance on Monday for how and when existing clinical data should be used to support pediatric medical device indications and labeling. The guidance ...

Survival extrapolation plays a pivotal role in cost-effectiveness analysis by extending observed clinical trial data to estimate long-term patient outcomes. Given that the follow‐up periods of trials ...