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# BIMO Electronic Submission Format Guidance
- URL: https://www.fdaweb.com/bimo-electronic-submission-format-guidance/
- Published: 2024-06-05T12:00:00.000Z
- Updated: 2026-09-14T14:32:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157117

FDA has published a draft guidance, *Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions*, that applies to electronic submissions of data and information from pivotal studies used to support safety and efficacy claims in BLAs and NDAs regulated by CBER, as well as supplemental applications containing new clinical study reports. When finalized, the [document](ttps://www.fda.gov/media/179136/download) will contain the same data and information requirements described in a CDER draft.

“CBER uses the data and information described in this guidance to plan bioresearch monitoring inspections, including to facilitate the timely identification of sites for inspection and to ensure that field investigators from the FDA Office of Regulatory Affairs, which is the office responsible for the conduct of the inspections, have the information needed to conduct the inspections,” the guidance says. “Twenty-four months after this draft guidance has been finalized, the data in BLAs and NDAs, and supplemental applications described in this guidance must be submitted electronically in the format specified in this guidance.”

The guidance contains an Introduction; Background; Description of Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and Summary-Level Clinical Site Dataset; and Submitting Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and Summary-Level Clinical Site Dataset.