FDA Withdraws Three Outdated Electronic Submission Guidances

October 5, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.

Rockville, MD (Sept. 28)-The US Food and Drug Administration (www.fda.gov) has withdrawn three guidances for industry: “Providing Submissions in Electronic Format-NDAs” (e-NDA), “Providing Regulatory Submissions in Electronic Format-ANDAs” (e-ANDA), and “Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.” These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.

Since releasing these guidances in 1999, FDA has adopted the International Conference on Harmonization (ICH) Common Technical Document (CTD), which has an electronic version (e-CTD) that recommends that the table of contents be submitted as an extensible markup language (XML) file instead of as a PDF file. The agency prefers the e-CTD’s XML format, which allows access to “a real-time, up-to-date, cumulative table of contents that provides easy and immediate access to all files included in an application, regardless of when they were included or in what submission they are located,” according to the FDA announcement (http://www.fda.gov/OHRMS/DOCKETS/98fr/99d-0054-nwl0001.pdf). The XML format also allows reviewers to evaluate the application in various discipline-specific views (e.g., clinical aspects for chemistry-related reviews).