Drug Development Tools: Fit-for-Purpose Initiative
Background
The Fit-for-Purpose (FFP) Initiative provides a pathway for regulatory acceptance of dynamic tools for use in drug development programs. Due to the evolving nature of these types of drug development tools (DDTs) and the inability to provide formal qualification, a designation of ‘fit-for-purpose’ (FFP) has been established. A DDT is deemed FFP based on the acceptance of the proposed tool following a thorough evaluation of the information provided. The FFP determination is made publicly available in an effort to facilitate greater utilization of these tools in drug development programs.
Contact Us
For more information about the FFP Initiative, please contact DrugDevelopmentTools@fda.hhs.gov
Fit-For-Purpose Tools and Supporting Information:
| Disease Area | Submitter | Tool | Trial Component | Issuance Date and Supporting Information |
|---|---|---|---|---|
| Alzheimer’s disease | The Coalition Against Major Diseases (CAMD) | Disease Model: Placebo/Disease Progression |
Demographics, Drop-out | Issued June 12, 2013 |
| Multiple | Janssen Pharmaceuticals and Novartis Pharmaceuticals | Statistical Method: MCP-Mod |
Dose-Finding | Issued May 26, 2016 |
| Multiple | Ying Yuan, PhD The University of Texas MD Anderson Cancer Center Department of Biostatistics |
Statistical Method: Bayesian Optimal Interval (BOIN) design |
Dose-Finding | Issued: December 10, 2021 |
| Multiple | Pfizer | Statistical Method: Empirically Based Bayesian Emax Models |
Dose-Finding | Issued: August 5, 2022 |