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Clinical research / Clinical pharmacology / Pharmacology / Pharmaceutical industry / Clinical Data Interchange Standards Consortium / Clinical investigator / Adverse Event Reporting System / Center for Biologics Evaluation and Research / Prescription Drug User Fee Act / Pharmaceutical sciences / Food and Drug Administration / Research


CDER Data Standards Strategy – Action Plan
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Company

Alteon Inc. / /

Event

FDA Phase / /

Facility

Duke Clinical Research Institute / Critical Path Institute / /

IndustryTerm

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 / Federal government / Center for Drug Evaluation and Research / office of Generic Drugs / Data Standards Program Board / Food and Drug Administration / Standards Development Organization / Coalition for the Advancement of Standards and Therapies / CDER DSPB / office of Regulatory Policy / FY2013 Q1 IDMP Implementation CDER Implement International Organization for Standardization / /

Position

investigator / Clinical Investigator Information complete FY13 Q1 / /

Product

FY13 / Q2 / /

ProgrammingLanguage

XML / /

Technology

XML / Biotechnology / /

URL

http /

SocialTag