Thursday, February 16, 2006
Electronic Common Technical Document (eCTD)
Electronic Common Technical Document (eCTD): "FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process.
1. Review the eCTD specifications
The following are the specifications for creating the eCTD Backbone Files and Study Tagging Files (eCTD Specifications). The specifications are listed below.
* Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications. [HTML] or [Word] or [PDF]. (Issued and posted 10/18/2005)
* ICH eCTD Specification 3.2 (131 pages)
* Demonstration of FDA eCTD System (coming soon)
* Electronic Common Technical Document (eCTD) Tutorial, 4/22/2005, Rockville, MD Agenda and Presentations (4/26/2005)
* Other Recent Presentations"
1. Review the eCTD specifications
The following are the specifications for creating the eCTD Backbone Files and Study Tagging Files (eCTD Specifications). The specifications are listed below.
* Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications. [HTML] or [Word] or [PDF]. (Issued and posted 10/18/2005)
* ICH eCTD Specification 3.2 (131 pages)
* Demonstration of FDA eCTD System (coming soon)
* Electronic Common Technical Document (eCTD) Tutorial, 4/22/2005, Rockville, MD Agenda and Presentations (4/26/2005)
* Other Recent Presentations"
# posted by Dr. Martin Menzel @ 10:42 PM 
