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Medicine / Food and Drug Administration / Medical informatics / Clinical Data Management / Pharmaceutical industry / Clinical Data Interchange Standards Consortium / Clinical investigator / Center for Biologics Evaluation and Research / Electronic Common Technical Document / Pharmaceutical sciences / Clinical research / Research


Data Standards Strategy – Action Plan Version: 1.1 Document Date: July 29, 2013
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Facility

Duke Clinical Research Institute / Critical Path Institute / /

IndustryTerm

medicinal product / technology vendors / manufacturing establishments / generic products / /

Organization

FDA / CDER’s DSPB / office of Biotechnology / office of New Drug Quality Assessment / Critical Path Institute / Duke Clinical Research Institute / Center for Drug Evaluation and Research / office of Generic Drugs / Data Standards Program Board / Food and Drug Administration / ISO IDMP / Standards Development Organization / Organization for Standardization / Coalition for the Advancement of Standards and Therapies / CDER DSPB / office of Regulatory Policy / /

Technology

RDF / Biotechnology / /

URL

http /

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