Drug Development Tools

  • Drug Development Tool (DDT): Animal Model Qualification Program
  • Drug Development Tool (DDT): Biomarker Qualification Program
  • Drug Development Tool (DDT): Clinical Outcomes Assessment Program

Please submit comments for any of the guidances posted in the Drug Development Tools website to the Division of Dockets Management (DDM) under Docket FDA-XXXX-X-XXXX-XXXX. For electronic comments refer to the website http://www.regulations.gov OR you can mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov HelpDesk at 1-877-378-5457 (toll free) for assistance regarding submissions. 

Drug Development Tools Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry (PDF - 39KB) Final Guidance 09/14/16
Procedural /Clinical/Medical Qualification Process for Drug Development Tools (PDF - 499KB) Final Guidance 01/06/14
Drug Development Tools Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry (PDF - 32KB) Final Guidance 09/15/16
Drug Development Tool Guidance on Qualification of Biomarker — Galactomannan in studies of treatments of invasive Aspergillosis (PDF - 141KB) Final Guidance 11/13/15
Drug Development Tools Biomarker Qualification: Evidentiary Framework (PDF - 346KB) Draft Guidance 12/11/18

Page Last Updated: 12/11/2018
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