Experience with voluntary and required genomic data submissions to the FDA: summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop.
Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993-0002, USA. Felix.Frueh@FDA.gov
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D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods; D017277:Drug Approval; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods; D023281:Genomics; D017408:Guidelines as Topic; D006801:Humans; D019221:Mandatory Reporting; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence; D011050:Policy Making; D012107:Research Design / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration; D014836:Volition