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# Regulatory Submission Alternate Electronic Format
- URL: https://www.fdaweb.com/regulatory-submission-alternate-electronic-format/
- Published: 2021-07-06T12:00:00.000Z
- Updated: 2026-09-14T17:05:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149634

FDA has issued a guidance, *Providing Regulatory Submissions in Alternate Electronic Format*, with recommendations on an alternate electronic format for submissions covered under an exemption from or waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act. The recommendations pertain to the format of content in NDAs, ANDAs, certain drug master files, certain BLAs, and certain INDs submitted to CDER or CBER. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-alternate-electronic-format-guidance-industry?ref=fdaweb.com) says sponsors and applicants who receive an exemption or waiver from filing in electronic common technical document format should still provide those exempted or waived submissions electronically.