In July, we reported that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) had announced a joint proposal to promote the use of innovative approaches to paediatric drug development. We noted that the EMA expected to publish a Reflection Paper setting out a systematic approach to extrapolation of paediatric data by the end of the year. This has now been published.

Continue Reading EMA Reflection Paper on paediatric extrapolation