Drugs

Drug Development Tools (DDT) Letters of Support

What is a Letter of Support?

This is a letter issued to a submitter that briefly describes CDER’s thoughts on the potential value of a biomarker and encourages further evaluation. This letter does not connote qualification of a biomarker. It is meant to enhance the visibility of the biomarker, encourage data sharing, and stimulate additional studies.

Why Issue a Letter of Support?

Encouraging the identification and qualification of new drug development tools has been recognized as one of the approaches to overcome hurdles in drug development programs.  This approach has the potential to enhance the availability of useful information about drug safety and efficacy. To encourage further development of promising biomarkers which are not yet ready for qualification, FDA may issue a Letter of Support to submitters who have assembled this information about promising biomarkers.

How to Request a Letter of Support?

Information and Templates:

For more information, please contact CDER-BiomarkerQualificationProgram@fda.hhs.gov.

 

Issued Letters of Support

Submitter
Biomarkers
Area(s) for Further Evaluation
Issuance Date with Link to Letter of Support
Submitter Contact

Critical Path Institute's (C-Path) Predictive Safety Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)

Urinary Biomarkers: Osteopontin and Neutrophil Gelatinase-associated Lipocalin (NGAL)

Early Clinical Drug Development

8/20/2014: Letter of Support (PDF)

Refer to Predictive Safety Testing Consortiumdisclaimer icon Web Site

C-Path, PSTC, Skeletal Muscle Working Group (SMWG)

Serum and Plasma Biomarkers: Myosin Light Chain 3 (Myl3), Skeletal Muscle Troponin I (sTNI),  Fatty Acid Binding Protein 3 (FABP3), Creatine Kinase, Muscle Type (CK-M, the Homodimer CK-MM)

Early Clinical Drug Development

1/22/2015: Letter of Support (PDF)

Refer to Predictive Safety Testing Consortiumdisclaimer icon Web Site

C-Path, Coalition Against Major Diseases Consortium (CAMD)

Cerebral Spinal Fluid (CSF) Analyte Biomarkers: Aβ1-42, Total tau, Phosphotau

Exploratory Prognostic Biomarkers for Enrichment in Early Stage Alzheimer’s Disease Clinical Trials

2/26/2015: Letter of Support (PDF)

Refer to Coalition Against Major Diseasesdisclaimer icon Web Site

C-Path, CAMD

Magnetic Resonance Imaging Biomarker: Low Baseline Hippocampal Volume

Exploratory Prognostic Biomarkers for Enrichment in Early Stage Alzheimer's Disease Clinical Trials

3/10/2015: Letter of Support (PDF)

Refer to Coalition Against Major Diseasesdisclaimer icon Web Site

C-Path, CAMD

Molecular Neuroimaging Biomarker: Dopamine Transporter (DAT)

Exploratory Prognostic Biomarkers for Enrichment in Early Stage Parkinson's Disease Clinical Trials

3/16/2015: Letter of Support (PDF)

Refer to Coalition Against Major Diseasesdisclaimer icon Web Site

C-Path, Polycystic Kidney Disease (PKD) Outcomes Consortium

MRI, Computerized Tomography (CT), or Ultrasound (US) Biomarker: Total Kidney Volume (TKV)

Exploratory Prognostic Biomarker for Enrichment in Autosomal Dominant Polycystic Kidney

4/23/2015: Letter of Support (PDF)

Refer to Polycystic Kidney Disease Outcomes Consortiumdisclaimer icon Web Site

Memorial Sloan-Kettering Cancer Center, Medivation Inc., and Janssen Diagnostics, LLC

Circulating Tumor Cell (CTC) Enumeration

Disease Activity Biomarker for use in Metastatic Castration-resistant Prostate Cancer (mCRPC)

9/25/2015: Letter of Support (PDF)

Debra J. Rasmussen 

Xhale, Inc.

2-Butanone in Human Breath

Monitoring Biomarker to Evaluate Drug-Dosing Compliance on a Dose-by-Dose Basis

11/19/2015: Letter of Support (PDF)

Donn Dennis

 

Page Last Updated: 04/20/2016
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