2005N-0393 Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
FDA Comment Number : EC1
Submitter : Dr. Michelle Tallin Date & Time: 12/13/2005 10:12:59
Organization : Dr. Michelle Tallin
Category : Drug Industry
Issue Areas/Comments
GENERAL
GENERAL
We suggest that FDA offer additional clarity in regards to the IND regulations (21 CFR ? 312.23, IND Content and Format) as they pertain to initial IND?s submitted in the ICH Common Technical Document (CTD) format. We suggest that these regulations be organized in a manner consistent with the content and format required of an IND in CTD format. The current regulations outline the format of an IND by Items (1 through 11) rather than by Modules (1 through 5). The intent of the CTD format was to harmonize the content and format for New Drug Applications across the tripartite regions, however it is often not clear how this format applies to the content and format of an IND. If the regulations were organized in a manner consistent with CTD format, companies would be better positioned to meet Agency expectations.