FDA Issues Draft Guidance for Pharmacogenomic Data Submissions

Rockville, MD (Aug. 29)-The US Food and Drug Administration issued a draft guidance, Pharmacogenomic Data Submissions Companion Guidance, to be used as a companion to an earlier guidance, Pharmacogenomic Data Submissions, which was issued in March 2005. The draft guidance explains the procedure for voluntary genomic data submissions and marketing submissions containing genomics data. These submissions can be part of investigational new drug applications, new drug applications, and biologics license applications. The recommendations are intended to facilitate progress in pharmacogenomics and pharmacogenomic data use in drug development.

The draft guidance addresses methodological issues that should be considered when submitting gene expression data from microarrays, including:

• RNA isolation, handling, and characterization

• Labeling systems

• Hybridizations for microarrays

• Fluorescence reader settings for microarrays

• Differentially expressed genes

• Genotyping

• Proficiency testing.

Comments about the draft guidance are due Nov. 27, 2007. Notice of the draft guidance was published in Federal Register 72 (167), 49722–49723 (2007).