Stuck in the MIDD-le

An FDA meeting to discuss evidentiary standards for model-informed drug development revealed concerns that rigid regulatory requirements could undermine the utility of the approach. Rather than specifying requirements for qualifying models as EMA has done, panelists suggested FDA should make clear what types of information it needs from sponsors to evaluate models based on the logic that goes into constructing them.

Differences in these approaches represent a trade-off between the amount of data and near-term investment required to qualify a model for repeated use, and the amount of effort required over the long term to validate a model for every application...