title: The impact of FDA guidance on pharmacogenomic data submissions on drug development.
abstract: After a long wait, the US Food and Drug Administration (FDA) finally released the much anticipated 'Guidance on Pharmacogenomic Data Submissions on Drug Development' in March 2005, but what impact will this have on the drug industry as a whole? It is becoming increasingly apparent that the field of pharmacogenomics can add value to both clinical trial design and the drug development process, but uptake by the pharmaceutical industry has so far been variable between companies. The opinion of the FDA is that the use of pharmacogenomics in drug development is a 'good thing' and one that it wishes to promote, hence, this new guidance is designed to assist drug companies to adopt pharmacogenomic technology in clinical development, and covers both targeted and exploratory aspects. While targeted pharmacogenomics must be included as part of any regulatory submission, exploratory approaches may be submitted voluntarily with assurances from the FDA that any such submissions will not be used to make regulatory decisions. With this regulatory framework now in place it is only a matter of time before it is known how the industry reacts and the impact it will have on drug development.
authors.affiliation: DxS Ltd, Manchester, UK. stephen.little@dxsgenotyping.com
authors.forename: Stephen
authors.initials: S
authors.lastname: Little
mesh_terms: D030541:Databases, Genetic; D018390:Gene Targeting; D017408:Guidelines as Topic; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence* / Q000592:standards / Q000639:trends*; D010600:Pharmacology / Q000331:legislation & jurisprudence* / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration