( ock. The guidance Pharmacogenomic D...)FDA Works To Speed The Advent Of New, More Effective Personalized Medicines

The guidance "Pharmacogenomic Data Submissions," clarifies how pharmacogenomic data will be evaluated. The final guidance describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision making. The guidance also explains a new mechanism for industry to voluntarily submit research data to further the scientific exchange of information as we move into more advanced areas of pharmacogenomic research. The voluntary data, which will be reviewed by an internal, agency-wide group and will not be used for regulatory decision making, will help FDA and industry gain valuable experience as this new field continues to evolve.

FDA believes this approach will save time and resources and eliminate possible delays in the application review process because parties will be able to familiarize themselves with novel pharmacogenomic approaches as they evolve.

FDA's new pharmacogenomics Web page is available. The Web site ("Genomics at FDA") will be useful to industry because it includes detailed information on submitting genomic data, including a decision tree to simplify data submissions, relevant regulatory information, and FDA contact information.

FDA has already received several pharmacogenomic data submissions through both the regulatory and voluntary processes and will continue to work closely with industry and the healthcare community on this exciting emerging technology.

In addition to announcing the availability of its final guidance and the new pharmacogenomic Web page, the agency also reminded the public of the April 11 to 13 meeting being held at the Mariott Hotel in Bethesda , MD on pharmacogenomics issues. The meeting is being sponsored jointly by FDA and the Drug Information Association. The joint FDA/DIA meeting, "Pharmacogenomics in Drug Development and Regulat
'"/>

Source:FDA