| Document Date: 2014-08-18 12:33:59
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City SHANGHAI / SAN FRANCISCO / NEW YORK / SEOUL / BEIJING / Silicon Valley / WASHINGTON / LONDON / SAN DIEGO / BRUSSELS / / Company COVINGTON & BURLING LLP / / / Event FDA Phase / Product Issues / Reorganization / / Facility Wisconsin Bar / / IndustryTerm risk devices / drug practice / applications / therapeutic product / particular manufacturer / diagnostic device / “during product / risk device / food / diagnostic devices / marketing applications / investigational devices / combination product / therapeutic products / combination products / investigational device / device manufacturer / / MedicalCondition different disease / disease / / MedicalTreatment drug therapy / / Organization Food and Drug Administration / FDA Center / US Federal Reserve / office of Combination Products / FDA / / Person Ellen J. Flannery Scott / Krista Hessler Carver Christopher Hanson / / / Product information / individually specified drug / Class II / BLA supplement / / ProvinceOrState Indiana / New York / District of Columbia / Washington / DC / / Technology diagnostic tests / human genome / / URL www.cov.com / http /
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E-ALERT | Food & Drug August 18, 2014 FDA ISSUES FINAL GUIDANCE ON "IN VITRO COMPANION DIAGNOSTIC DEVICES" On July 31, 2014, the Food and Drug Administration (FDA) released a final guidance entitled “In Vitro Companion