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The Electronic Common Technical Document: One Organization's Experience

Thursday, October 11, 2012 — Poster Session IV

2:00 p.m. – 4:00 p.m.

Natcher Conference Center, Building 45




  • L.H. Giambarresi
  • S.C. Garrand
  • M.A. Chakrabarti
  • V.S. Eccard
  • A.L. Gonzalez-Rodriguez
  • T.B. Harvey
  • J.M. Hertsch
  • L.M. Lacuesta
  • M.J. Buehn


Preparation and submission of Investigational New Drug applications, Master Files, and Investigational Device Exemption applications has traditionally been accomplished in hard copy paper format. Creating these applications in the electronic Common Technical Document (eCTD) format allows for the standardized presentation of all required technical, regulatory, and administrative information; reduces publication and delivery costs; and simplifies the Food and Drug Administration (FDA) review process. Here we describe the Regulatory Compliance and Human Subject Protection Program’s experience in transitioning from paper documents to an eCTD program for regulatory applications.

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