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  4. Drug Development Tools: Fit-for-Purpose Initiative
  1. Development & Approval Process | Drugs

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

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