THE ESTABLISHMENT OF AN ELECTRONIC REGULATORY SUBMISSION ENVIRONMENT FOR INVESTIGATIONAL NEW DRUG APPLICATIONS FOR BIOLOGICAL PRODUCTS

Abstract

The FDA is currently accepting INDs in both paper and electronic format. However, electronic regulatory submissions will eventually be obligatory. Making the transition now will prepare a company well in advance for mandatory electronic submissions. In March 1997. the FDA published regulations which set forth the criteria under which records submitted to FDA may be submitted in electronic format in place of paper (21 CFR Part 11). This paper presents guidelines for establishing an electronic regulatory submissions environment for INDs submitted to FDA CBER. The electronic regulatory submissions environment includes organizing and submitting the IND electronically and considerations for 21 CFR Part 11 compliance. A demonstration of an electronic IND is included on CD as Attachment 1. Detailed instructions for electronic IND file naming, and organization and for establishing an FDA ESG Production account are included in draft SOPs as Attachments 2 and 3, respectively.