The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program.
Drug developers have been using genomic information in drug development strategies for a number of years, but it was unclear how this information would be reviewed by the Food and Drug Administration (FDA). In order to evaluate the regulatory impact of genomic data in current drug development, a workshop was held in May 2002 to discuss aspects surrounding genomic data submission to the FDA (Figure 1).
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Genomics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. michael.orr@fda.hhs.gov
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D030541:Databases, Genetic; D004282:Documentation / Q000379:methods; D017277:Drug Approval / Q000379:methods; D004345:Drug Industry / Q000379:methods; D015894:Genome, Human / Q000235:genetics*; D006801:Humans; D017387:Investigational New Drug Application / Q000379:methods; D019221:Mandatory Reporting; D011640:Public Policy; D014481:United States