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Guidance for Industry: Submissions in Electronic Format
April 30, 1998
Washington, DC
DIA, In Cooperation with FDA and PhRMA
In September 1997, CDER published guidance for accepting electronic submission of case report forms (CRFs) and case report tabulations (CRTs) in Portable Document Format (PDF) without accompanying paper. In early April 1998, CDER expects to issue a draft guidance for public comment that describes how to submit these and all remaining parts of the New Drug Application (NDA) including how to submit related data files.
At this workshop, CDER representatives from the Office of Information Technology and the Electronic Submissions Technical Working Group will provide an overview of the draft guidance document, present an example of a full electronic submission, describe CDER's procedures for processing these electronic submissions, and discuss lessons learned from electronic submissions received since September 1997.
(Acrobat 3.0 or higher required)
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Draft Guidance for Industry, Regulatory Submissions in Electronic Format, David Isom
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Using PDF and SAS Transport for Electronic Submissions, Greg Brolund
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Providing Regulatory Submissions in Electronic Format - NDA, Randy Levin
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Submitting Archival Files to the CDER Electronic Document Room, Greg Warzala
(Posted 6/17/98)
Last update: July 11, 2005 |
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