FDA Details How to Use Alternate Electronic Format Submissions

The FDA has released final guidance on using an alternate electronic format for certain regulatory submissions in place of the agency’s standard electronic Common Technical Document (eCTD) format.

The alternate format does not require specialized XML coding or “other specific files needed for electronic display,” so commercial off-the-shelf software may be used, the agency said.

Submissions that use the alternate format must comply with the eCTD’s technical specifications for filing new drug applications, abbreviated new drug applications, certain drug master files, certain biologics license applications and certain investigational new drug applications.