FDA Releases Concept Paper on Pharmacogenomics

After nearly two years of receiving voluntary genomic data submissions as part of its pharmacogenomics guidance, the FDA has released a preliminary concept paper titled Pharmacogenomic Data Submissions.

After nearly two years of receiving voluntary genomic data submissions as part of its pharmacogenomics guidance, the FDA has released a preliminary concept paper titled Pharmacogenomic Data Submissions. The paper expands on the recommendations made in FDA’s guidance for industry on data submissions, issued in March 2005.

Based on its experience with voluntary genomic data submissions and with its review of numerous protocols and data submitted under investigational new drug applications, new drug applications, and biologics license applications during the last two years, FDA believes that guidance will benefit sponsors considering the submission of either voluntary genomic data or marketing applications containing genomics data.

The areas covered in the new document include gene expression data from microarrays including sections on RNA isolation, handling and characterization; labeling reactions, RNA labeling situations to be avoided; proficiency testing to avoid procedural failures; hybridizations for microarrays; fluorescence reader settings for microarrays; and differentially expressed genes and their biological interpretation.

The paper also elaborates on genotyping methods, and DNA isolation, handling and characterization. Genomic data in clinical study reports and from nonclinical toxicology studies, expanding the selection process criteria, and characterization of a particular compound are the other areas covered. A general scientific discussion concludes the paper.