Electronic Common Technical Document
The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format.
It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). As of January 1, 2008, the U.S. Food and Drug Administration announced that the eCTD is the preferred format for electronic submissions. To date, over 98,000 eCTD sequences have been submitted to the FDA. Although the agency has not released an expected target date, the FDA revealed during the 2009 DIA Annual Meeting that it is looking at draft legislation to require eCTD.
Read more about Electronic Common Technical Document: Pharmaceutical Point of View
Famous quotes containing the words electronic, common, technical and/or document:
“Ideally, advertising aims at the goal of a programmed harmony among all human impulses and aspirations and endeavors. Using handicraft methods, it stretches out toward the ultimate electronic goal of a collective consciousness.”
—Marshall McLuhan (1911–1980)
“The genius of any slave system is found in the dynamics which isolate slaves from each other, obscure the reality of a common condition, and make united rebellion against the oppressor inconceivable.”
—Andrea Dworkin (b. 1946)
“When you see something that is technically sweet, you go ahead and do it and you argue about what to do about it only after you have had your technical success. That is the way it was with the atomic bomb.”
—J. Robert Oppenheimer (1904–1967)
“What is a diary as a rule? A document useful to the person who keeps it, dull to the contempory who reads it, invaluable to the student, centuries afterwards, who treasures it!”
—Ellen Terry (1848–1928)