Drug Applications |
Agenda Electronic Investigational New Drug Application: Cumulative Table of Contents (CTOC); Public Meeting January 26, 2001 5630 Fishers Lane, Rockville, Maryland 8:30 9:30 am: Registration and Check-in 9:30 9:35 am: Opening Remarks 9:35 9:55 am: Life Cycle Management 9:55 10:15 am: The Role of the Table of Contents in the IND Review 10:15 10:35 am: Using XML 10:35 11:00 am: CTOC Beta Model Demonstration 11:00 11:30 am: CTOC Files 11:30 12:00 noon: Author Tool and Validator 12:00 1:30 pm: Lunch (on your own) 1:30 3:30 pm: Panel Discussion for the Following Points Would a cumulative table of contents offer you advantages? How difficult is it for you to create and maintain the XML files needed for the cumulative table of contents? How difficult will it be for you to incorpora te the preparation of an XML document in your submission preparation process?Do you have suggestions for improvements on the cumulative table of contents? Are you interested in piloting the cumulative table of contents in electronic IND's with the agenc y?Are you interested in working with us to develop tools to be used with the cumulative table of contents? Do you have other comments or suggestions? 3:30 3:50: Next Steps 3:50 4:00: Closing Comments FDA/Center for Drug Evaluation and Research |
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