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FDA Drafts Guidance for Regulatory Submissions in Alternate Electronic Format

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Background:

Guidance:

In the new draft guidance, FDA describes how to submit applications and other regulatory submissions in alternate electronic format, without extensible markup language (XML) backbone. Even though the alternate electronic format utilizes the same folder structure found in eCTD submissions, it does not include XML and other specific documents needed for electronic display and does not require specialized software.

The guidance describes the folder structure and organization of the alternate electronic format and providing recommendations to sponsors that plan to make submissions using the format. And it also applies to submissions and applications that are exempted or obtained a waiver from eCTD requirements, including new drug applications (NDAs) and abbreviated new drug applications (ANDAs), as well as certain DMFs, INDs and biologics license applications (BLAs).