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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 fitforpurpose@fda.hhs.gov

Fit-For-Purpose Tools and Supporting Information:

Disease AreaSubmitterToolTrial ComponentIssuance Date and Supporting Information
Alzheimer’s diseaseThe Coalition Against Major Diseases (CAMD)Disease Model:
Placebo/Disease Progression		Demographics, Drop-out

Issued June 12, 2013

MultipleJanssen Pharmaceuticals and Novartis PharmaceuticalsStatistical Method:
MCP-Mod		Dose-Finding

Issued May 26, 2016

MultipleYing 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

MultiplePfizerStatistical Method:
Empirically Based Bayesian Emax Models		Dose-Finding

Issued: August 5, 2022

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