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  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

The tool is freely available at: https://bitbucket.org/metrumrg/alzheimers-disease-progression-model-adascog/wiki/Home

Multiple Janssen Pharmaceuticals and Novartis Pharmaceuticals Statistical Method: MCP-Mod Dose-Finding

Issued May 26, 2016

 

 

 

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