This document was prepared by the National Health Council and Genetic Alliance with the intent of submission to the Food and Drug Administration to encourage adoption, wholly or in part, by the Agency.
Objectives for the recommended language offered in this document:
1. Convey to the public that the Food and Drug Administration supports and
encourages, but does not require, patient-focused drug development activities.
2. Provide definitions for the various terms used related to patient-focused drug
development to encourage standardization.