The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program.

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Published in Clin Pharmacol Ther on February 01, 2007

Authors

M S Orr1, F Goodsaid, S Amur, A Rudman, F W Frueh

Author Affiliations

1: 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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