> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Alternate e-Format Guide for Drugs/Biologics
- URL: https://www.fdaweb.com/alternate-e-format-guide-for-drugs-biologics/
- Published: 2022-06-24T12:00:00.000Z
- Updated: 2026-09-14T17:50:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152164

FDA has made available a [guidance](https://downloads.regulations.gov/FDA-2020-D-0420-0007/attachment%5F1.pdf?ref=fdaweb.com) entitled “Providing Regulatory Submissions in Alternate Electronic Format.” The document provides recommendations on an alternate electronic format for submissions that receive an exemption or a waiver from filing in the standard electronic common technical document (eCTD) format under Section 745A(a) of the FD&C Act. The guidance pertains to NDAs, ANDAs, BLAs, INDs and drug master files.