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FDA Issues Draft Guidance on Submission of Pharmacogenomic Data

NEW YORK, Nov. 3 (GenomeWeb News) - The US Food and Drug Administration has today issued a new draft guidance on submission of pharmacogenomic data.


The document, "Draft Guidance for Industry: Pharmacogenomic Data Submissions," provides recommendations and criteria for submission of pharmacogenomic data in investigational new drug applications, new drug applications, and biological license applications, the agency said. The document specifies which data is needed and how it will or will not be used in regulatory decision-making.


"Pharmacogenomics is a new field, but we intend to do all we can to use it to promote the development of medicines," FDA Commissioner Mark McClellan said in a statement. "By providing practical guidance on how to turn the explosion of pharmacogenomic information into real evidence on new drugs, we are taking an important step toward that goal."


The agency is asking for voluntary submissions of this research information, and advises sponsors to clearly label the information as such. It specified that it will not use this voluntary data for regulatory decisions.


The agency said it plans to issue further guidance on pharmacogenomic tests and pharmaceuticals "in the near future."