Biological Product
Electronic Investigational New Drug Application (eIND)
The attached demonstration model accurately reflects the high-level navigational capabilities (i.e., bookmark and table of contents) as well as folder structure for an electronic IND (eIND) as detailed within the CBER final guidance document on Electronic IND submissions promulgated on March 26, 2002. We have brought forward this simple demonstration model in order to aid Academia and Industry in their understanding of the eIND paradigm and guidance document. We encourage sponsors to liberally utilize hypertext links within their eIND presentation; these additional links will aid our reviewers in accessing submission information. That level of in document hypertext linking is not presented within this demonstration model.
- Electronic IND demo - zip file - 1.2 MB
- Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs) - 3/26/2002
If there are questions about the demo, please contact -
Michael Fauntleroy
301-827-5132
fauntleroy@cber.fda.gov
esubprep@cber.fda.gov