The FDA requested stakeholder feedback on its 2003 guidance on exposure-response analyses — prompted by PDUFA VI provisions on advancing model-informed drug development.

The agency is seeking comments on aspects of the guidance that may need clarity or on topic areas it fails to address, as well as on best practices for exposure-response analysis.

The potential best practices could relate to planning/design, analytical approaches, model evaluation and classification, and proper communications about results and how this affects later drug or regulatory decisions.

The FDA is also interested in feedback from stakeholders on what aspects of exposure-response analyses are most important during the drug development or regulatory decision-making process and on the barriers to widespread acceptance of such analyses.